Coronary Artery Disease (CAD), Ischemic Heart Disease
Conditions
Brief summary
This was a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in participants referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to assess the difference and variability between 2 sets of rest images synthesized by the same or 2 different manufacturing processes. Twenty-eight evaluable \[participants were enrolled in this study and underwent 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each participant attended a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The participants were randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 participants received 2 Flurpiridaz (18F) Injection doses synthesized by the same manufacturing processes (either HPLC or SPE) and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC). All participants were followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration.
Interventions
DRUGFlurpiridaz (18F) Injection
All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest.
Sponsors
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \* The participant was a man or woman ≥18 years of age * The participant was undergoing evaluation of known CAD or for suspected CAD with an intermediate to high PTP. * The participant had read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed, and was willing to allow the study investigator to make the participant's medical records available to GE Healthcare. * The participant was male or was a nonpregnant, nonlactating female who was either surgically sterile (had a documented bilateral tubal ligation and oophorectomy and/or documented hysterectomy \[bilateral tubal ligation alone was insufficient\]) or was post-menopausal (cessation of menses for more than 1 year); enrollment in the study without a pregnancy test at Screening was allowed for these categories of female participants. For women of childbearing potential, the results of either a urine or serum human chorionic gonadotropin pregnancy test (with the result known on the day of each radiopharmaceutical administration) must be negative. These participants must have been practicing appropriate birth control from the time of the screening to 30 days after the second radiopharmaceutical administration. Such methods included: hormonal contraception including oral contraceptives; intrauterine device; intrauterine hormone releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence; adequate barrier method with spermicide (e.g., diaphragm, condom). * The participant was able and willing to comply with all study procedures as described in the protocol.
Exclusion criteria
* \* Participants who were pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or were lactating * Participants who were unable to undergo all of the imaging procedures * Participant with unstable cardiovascular condition, including but not limited to: 1. Transient ischemic attack/stroke within 3 months of enrollment; 2. Significant congenital heart disease; 3. Uncontrolled hypertension; 4. Uncontrolled tachyarrhythmia led to symptoms or hemodynamic compromise. * Participants required cardiac intervention (i.e., percutaneous coronary intervention or coronary artery bypass graft) before completing the study. * Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant. * Participants with screening laboratory findings as follows: 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was greater than 3 times the upper limit of normal; 2. Total bilirubin ≥2.0 mg/dL (34.2 μmol/L); 3. Serum creatinine ≥3.0 mg/dL (265.2 μmol/L). * Participants who presented with any clinically active, serious, life-threatening disease, medical or psychiatric condition, and/or who have a life expectancy of \<6 months, or for whom study participation may compromise their management; and participants whom the investigator judges to be unsuitable for participation in the study for any reason. * Participants undergone evaluation for heart transplantation or with a history of heart transplantation. * Participants enrolled in another clinical study within the 30 days before enrollment in this study. * Participants previously enrolled in this study or any Flurpiridaz (18F) Injection study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Up to 2 weeks | 3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader difference of SRS for PET MPI was reported. |
| Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Up to 2 weeks | 3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Summed score of the 17 segments SRS was used for analysis. SR% is calculated by dividing the SRS by a number corresponding to the SRS value indicating a deficit of 4 in every segment and then multiplying the result by 100. Intra-reader difference of SR% for PET MPI was reported. |
| Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Up to 2 weeks | 3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Pearson's correlation was reported. |
| Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Up to 2 weeks | 3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Kendall's tau-b was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Up to 2 weeks | Relative difference was calculated as 100 (SUV1-SUV2) / (0.5\*\[SUV1 + SUV2\]) and SUV was calculated as Decay Corrected Uptake (kBq/cc) / (Injected Dose \[MBq\] / Weight \[kg\]). Relative difference in SUV of TACs by region after MPI sessions using 2 Flurpiridaz (18F) injection doses synthesized by same and 2 different manufacturing processes was reported. |
| Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Up to 2 weeks | Image quality scoring was performed as following: SPE image was worse than HPLC image when the difference (SPE - HPLC) score was less than or equal (\<=)-3. SPE image was slightly worse than HPTC image when the difference score was \<=-1 and greater than (\>)-3. SPE and HPLC images were the same when the difference score was \>-1 and less than (\<) 1. SPE image was slightly better when the difference score \>=1 and \<3. SPE image was better when the difference was \>=3. Higher score indicates better outcomes. Number of participants categorized based on intra-reader agreement of the image quality score between the 2 Sets of PET images for 2 Flurpiridaz (18F) injection doses from different manufacturing processes was reported. |
| Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process | Up to 2 weeks | Variability of SRS was estimated by using the SD of the paired difference divided by square root of 2. SRS was used for myocardial perfusion defects examination. The independent reads of all MPI images were based on standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Variability of the SRS after MPI sessions using 2 Flurpiridaz (18F) injection doses by the same process was reported. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From screening up to end of follow up (up to 30 days) | A TEAE was defined as an adverse events (AE) that occurred from the time of investigational medicinal product (IMP) administration through the end of the follow-up period for the corresponding dose. Any medication error, clinically significant vital signs, electrocardiograms (ECGs), hematology, clinical chemistry laboratory tests, and urinalysis values determined by investigator were reported as TEAEs. Number of participants with TEAEs and serious TEAEs were reported. |
| Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Up to 2 weeks | Image quality scoring was performed as following: 2 images were the same when the absolute difference score was \>=0 and \<1. 2 images were slightly different when the absolute difference score \>=1 and \<3. 2 images were different when the absolute difference score \>=3. Higher score indicates better outcomes. Number of participants categorized based on intra-reader agreement of the image quality score between the 2 sets of PET Images for 2 Flurpiridaz (18F) injection doses from same manufacturing processes was reported. |
| Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Up to 2 weeks | Percentage of participants with intra-reader agreement of the detected ischemic defect on PET-MPI was reported. |
| Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Up to 2 weeks | Perfusion rest score was used for myocardial perfusion defects examination. The independent reads of all MPI images were based on standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal: 0; Minimal, mild impairment of perfusion, ambiguous image: 1; Moderate impairment of perfusion: 2; Significant impairment of perfusion: 3, No perfusion: 4. Higher score indicates impairment. Mean of the paired difference between the perfusion rest scores from 2 manufacturing processes for each of the 17 segments and each reader for 2 Flurpiridaz (18F) injection doses from same and different manufacturing process was reported. |
| Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Up to 2 weeks | Difference was calculated by (Mean SUV from the second injection - Mean SUV from the first injection). SUV was calculated as Decay Corrected Uptake (kBq/cc) / (Injected Dose \[MBq\] / Weight (kilogram \[kg\]). Difference in SUV of TACs by region after MPI sessions using 2 Flurpiridaz (18F) injection doses synthesized by same and 2 different manufacturing processes was reported. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 5 centers in the United States from 27 January 2022 and 26 May 2022.
Pre-assignment details
A total of 38 participants were enrolled, of which 35 were randomized into 1 of 4 sequences: Solid phase extraction (SPE)-SPE, high performance liquid chromatography (HPLC)-HPLC, SPE-HPLC, HPLC-SPE) to receive either 2 doses of Flurpiridaz (18F) Injection manufactured by the same process (HPLC or SPE) or 2 doses manufactured by different processes (1 dose by HPLC and 1 dose by SPE in a random order).
Participants by arm
| Arm | Count |
|---|---|
| Treatment Sequence: SPE-SPE Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. | 7 |
| Treatment Sequence: HPLC-HPLC Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. | 10 |
| Treatment Sequence: SPE-HPLC Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by SPE followed by 1 dose manufactured by HPLC) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. | 11 |
| Treatment Sequence: HPLC-SPE Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by HPLC followed by 1 dose manufactured by SPE) at Visit 1 and 2.
The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. | 7 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Other | 0 | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment Sequence: SPE-SPE | Treatment Sequence: HPLC-HPLC | Treatment Sequence: SPE-HPLC | Treatment Sequence: HPLC-SPE | Total |
|---|---|---|---|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 7.3 | 62.7 years STANDARD_DEVIATION 8.71 | 66.0 years STANDARD_DEVIATION 9.75 | 63.1 years STANDARD_DEVIATION 10.3 | 64.8 years STANDARD_DEVIATION 8.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 7 Participants | 5 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 6 Participants | 4 Participants | 2 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 7 Participants | 11 Participants | 6 Participants | 30 Participants |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 3 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 10 Participants | 8 Participants | 4 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 3 / 25 | 1 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Kendall's tau-b was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, overall number of participants analyzed was the number of participants in MITT population for each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz (18F): SPE | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 2 | 0.856 Correlation coefficient of score |
| Flurpiridaz (18F): SPE | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 1 | 1.000 Correlation coefficient of score |
| Flurpiridaz (18F): SPE | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 3 | 1.000 Correlation coefficient of score |
| Flurpiridaz (18F): HPLC | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 2 | 0.872 Correlation coefficient of score |
| Flurpiridaz (18F): HPLC | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 1 | 0.732 Correlation coefficient of score |
| Flurpiridaz (18F): HPLC | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 3 | 0.733 Correlation coefficient of score |
| Flurpiridaz (18F): SPE vs. HPLC | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 1 | 0.769 Correlation coefficient of score |
| Flurpiridaz (18F): SPE vs. HPLC | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 3 | 0.833 Correlation coefficient of score |
| Flurpiridaz (18F): SPE vs. HPLC | Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b | Reader 2 | 0.869 Correlation coefficient of score |
Comparison: Reader 1p-value: 0.0089Wilcoxon Signed Rank Test
Comparison: Reader 2p-value: 0.0207Wilcoxon Signed Rank Test
Comparison: Reader 3p-value: 0.0089Wilcoxon Signed Rank Test
Comparison: Reader 1p-value: 0.732Wilcoxon Signed Rank Test
Comparison: Reader 2p-value: 0.0083Wilcoxon Signed Rank Test
Comparison: Reader 3p-value: 0.0412Wilcoxon (Mann-Whitney)
Comparison: Reader 1p-value: 0.0001Wilcoxon Signed Rank Test
Comparison: Reader 2p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Reader 3p-value: <0.0001Wilcoxon Signed Rank Test
Primary
Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Pearson's correlation was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, overall number of participants analyzed was the number of participants in MITT population for each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz (18F): SPE | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 2 | 0.997 Correlation coefficient of score |
| Flurpiridaz (18F): SPE | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 1 | 1.000 Correlation coefficient of score |
| Flurpiridaz (18F): SPE | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 3 | 0.999 Correlation coefficient of score |
| Flurpiridaz (18F): HPLC | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 2 | 0.905 Correlation coefficient of score |
| Flurpiridaz (18F): HPLC | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 1 | 0.890 Correlation coefficient of score |
| Flurpiridaz (18F): HPLC | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 3 | 0.931 Correlation coefficient of score |
| Flurpiridaz (18F): SPE vs. HPLC | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 1 | 0.787 Correlation coefficient of score |
| Flurpiridaz (18F): SPE vs. HPLC | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 3 | 0.910 Correlation coefficient of score |
| Flurpiridaz (18F): SPE vs. HPLC | Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation | Reader 2 | 0.881 Correlation coefficient of score |
Comparison: Reader 1p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Reader 2p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Reader 3p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Reader 1p-value: 0.0072Wilcoxon Signed Rank Test
Comparison: Reader 2p-value: 0.0051Wilcoxon Signed Rank Test
Comparison: Reader 3p-value: 0.0023Wilcoxon Signed Rank Test
Comparison: Reader 1p-value: 0.0002Wilcoxon Signed Rank Test
Comparison: Reader 2p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Reader 3p-value: <0.0001Wilcoxon Signed Rank Test
Primary
Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Summed score of the 17 segments SRS was used for analysis. SR% is calculated by dividing the SRS by a number corresponding to the SRS value indicating a deficit of 4 in every segment and then multiplying the result by 100. Intra-reader difference of SR% for PET MPI was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. A participant received SPE in both periods was counted twice in SPE group and a participant received HPLC in both periods was counted twice in HPLC group, while a participant received both methods was counted once in each group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Flurpiridaz (18F): SPE | Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Median of Readers | 9.797 percentage of score | Standard Error 2.673 |
| Flurpiridaz (18F): SPE | Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Reader 1 | 9.168 percentage of score | Standard Error 2.714 |
| Flurpiridaz (18F): SPE | Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Reader 2 | 10.307 percentage of score | Standard Error 3.023 |
| Flurpiridaz (18F): SPE | Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Reader 3 | 10.789 percentage of score | Standard Error 2.692 |
| Flurpiridaz (18F): HPLC | Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Reader 3 | 10.655 percentage of score | Standard Error 2.692 |
| Flurpiridaz (18F): HPLC | Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Median of Readers | 9.578 percentage of score | Standard Error 2.673 |
| Flurpiridaz (18F): HPLC | Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Reader 2 | 9.200 percentage of score | Standard Error 3.023 |
| Flurpiridaz (18F): HPLC | Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI | Reader 1 | 9.146 percentage of score | Standard Error 2.714 |
Comparison: Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect.p-value: 0.845290% CI: [-2.104, 1.667]Mixed-effects model for repeated measure
Comparison: Reader 1: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect.p-value: 0.98990% CI: [-2.793, 2.747]Mixed-effects model for repeated measure
Comparison: Reader 2: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect.p-value: 0.385290% CI: [-3.241, 1.027]Mixed-effects model for repeated measure
Comparison: Reader 3: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect.p-value: 0.92690% CI: [-2.552, 2.285]Mixed-effects model for repeated measure
Primary
Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader difference of SRS for PET MPI was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. A participant received SPE in both periods was counted twice in SPE group and a participant received HPLC in both periods was counted twice in HPLC group, while a participant received both methods is counted once in each group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Flurpiridaz (18F): SPE | Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Median of Readers | 6.662 score on a scale | Standard Error 1.818 |
| Flurpiridaz (18F): SPE | Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Reader 2 | 7.009 score on a scale | Standard Error 2.056 |
| Flurpiridaz (18F): SPE | Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Reader 1 | 6.235 score on a scale | Standard Error 1.846 |
| Flurpiridaz (18F): SPE | Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Reader 3 | 7.336 score on a scale | Standard Error 1.831 |
| Flurpiridaz (18F): HPLC | Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Reader 3 | 7.246 score on a scale | Standard Error 1.831 |
| Flurpiridaz (18F): HPLC | Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Median of Readers | 6.513 score on a scale | Standard Error 1.818 |
| Flurpiridaz (18F): HPLC | Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Reader 1 | 6.219 score on a scale | Standard Error 1.846 |
| Flurpiridaz (18F): HPLC | Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) | Reader 2 | 6.256 score on a scale | Standard Error 2.056 |
Comparison: Median of Readers: SPE VS HPLC~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect.p-value: 0.845290% CI: [-1.431, 1.133]Mixed-effects model for repeated measure
Comparison: SPE VS HPLC: Reader 1~Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect.p-value: 0.98990% CI: [-1.899, 1.868]Mixed-effects model for repeated measure
Comparison: Reader 2: SPE VS HPLC~Reader 2: Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect.p-value: 0.385290% CI: [-2.204, 0.698]Mixed-effects model for repeated measure
Comparison: Reader 3: SPE VS HPLC~Analysis was based on MMRM model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect.p-value: 0.92690% CI: [-1.735, 1.554]Mixed-effects model for repeated measure
Secondary
Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
Perfusion rest score was used for myocardial perfusion defects examination. The independent reads of all MPI images were based on standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal: 0; Minimal, mild impairment of perfusion, ambiguous image: 1; Moderate impairment of perfusion: 2; Significant impairment of perfusion: 3, No perfusion: 4. Higher score indicates impairment. Mean of the paired difference between the perfusion rest scores from 2 manufacturing processes for each of the 17 segments and each reader for 2 Flurpiridaz (18F) injection doses from same and different manufacturing process was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, overall number of participants analyzed was the number of participants in MITT population for each treatment group.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 11 - Mid Inferolateral | -0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 3 - Basal Inferoseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 6 - Basal Anterolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 6 - Basal Anterolateral | 0.286 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 2 - Basal Anteroseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 7 - Mid Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 14 - Apical Septal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 1 - Basal Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 8 - Mid Anteroseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 12 - Mid Anterolateral | 0.429 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 5 - Basal Inferolateral | 0.429 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 9 - Mid Inferoseptal | -0.429 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 1 - Basal Anterior | -0.429 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 4 - Basal Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 10 - Mid Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 13 - Apical Anterior | 0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 17 - Apex | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 11 - Mid Inferolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 13 - Apical Anterior | 0.571 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 16 - Apical Lateral | -0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 12 - Mid Anterolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 8 - Mid Anteroseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 15 - Apical Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 13 - Apical Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 12 - Mid Anterolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 14 - Apical Septal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 14 - Apical Septal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 3 - Basal Inferoseptal | -0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 11 - Mid Inferolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 15 - Apical Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 17 - Apex | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 10 - Mid Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 16 - Apical Lateral | 0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 9 - Mid Inferoseptal | -0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 9 - Mid Inferoseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 17 - Apex | -0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 2 - Basal Anteroseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 8 - Mid Anteroseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 1 - Basal Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 16 - Apical Lateral | 0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 7 - Mid Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 2 - Basal Anteroseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 10 - Mid Inferior | -0.143 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 6 - Basal Anterolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 3 - Basal Inferoseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 7 - Mid Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 5 - Basal Inferolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 4 - Basal Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 15 - Apical Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 4 - Basal Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 5 - Basal Inferolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 7 - Mid Anterior | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 6 - Basal Anterolateral | -0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 7 - Mid Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 8 - Mid Anteroseptal | -0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 9 - Mid Inferoseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 10 - Mid Inferior | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 11 - Mid Inferolateral | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 12 - Mid Anterolateral | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 13 - Apical Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 14 - Apical Septal | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 15 - Apical Inferior | -0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 16 - Apical Lateral | -0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 17 - Apex | -0.571 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 1 - Basal Anterior | 0.429 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 2 - Basal Anteroseptal | 0.429 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 3 - Basal Inferoseptal | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 4 - Basal Inferior | 0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 5 - Basal Inferolateral | -0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 6 - Basal Anterolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 7 - Mid Anterior | 0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 8 - Mid Anteroseptal | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 9 - Mid Inferoseptal | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 10 - Mid Inferior | 0.429 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 11 - Mid Inferolateral | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 12 - Mid Anterolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 13 - Apical Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 14 - Apical Septal | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 15 - Apical Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 16 - Apical Lateral | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 17 - Apex | 0.857 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 3 - Basal Inferoseptal | 0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 4 - Basal Inferior | 0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 1 - Basal Anterior | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 2 - Basal Anteroseptal | -0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 3 - Basal Inferoseptal | -0.714 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 4 - Basal Inferior | 0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 5 - Basal Inferolateral | 0.714 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 6 - Basal Anterolateral | -0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 5 - Basal Inferolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 8 - Mid Anteroseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 9 - Mid Inferoseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 10 - Mid Inferior | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 11 - Mid Inferolateral | 0.571 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 12 - Mid Anterolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 13 - Apical Anterior | -0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 14 - Apical Septal | 0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 15 - Apical Inferior | -0.143 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 16 - Apical Lateral | 0.000 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 17 - Apex | 0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 1 - Basal Anterior | 0.286 Difference of scores |
| Flurpiridaz (18F): HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 2 - Basal Anteroseptal | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 14 - Apical Septal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 3 - Basal Inferoseptal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 4 - Basal Inferior | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 10 - Mid Inferior | -0.294 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 4 - Basal Inferior | 0.235 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 3 - Basal Inferoseptal | -0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 1 - Basal Anterior | -0.235 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 5 - Basal Inferolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 2 - Basal Anteroseptal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 15 - Apical Inferior | -0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 6 - Basal Anterolateral | -0.471 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 1 - Basal Anterior | -0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 9 - Mid Inferoseptal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 7 - Mid Anterior | -0.235 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 17 - Apex | 0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 6 - Basal Anterolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 8 - Mid Anteroseptal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 16 - Apical Lateral | -0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 16 - Apical Lateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 9 - Mid Inferoseptal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 15 - Apical Inferior | 0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 8 - Mid Anteroseptal | -0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 10 - Mid Inferior | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 14 - Apical Septal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 5 - Basal Inferolateral | 0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 11 - Mid Inferolateral | 0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 13 - Apical Anterior | 0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 13 - Apical Anterior | -0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 14 - Apical Septal | 0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 12 - Mid Anterolateral | -0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 17 - Apex | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 15 - Apical Inferior | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 11 - Mid Inferolateral | 0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 12 - Mid Anterolateral | -0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 16 - Apical Lateral | -0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 10 - Mid Inferior | 0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 12 - Mid Anterolateral | 0.235 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 17 - Apex | -0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 7 - Mid Anterior | -0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 3 - Basal Inferoseptal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 9 - Mid Inferoseptal | -0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 13 - Apical Anterior | 0.412 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 4 - Basal Inferior | -0.235 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 8 - Mid Anteroseptal | 0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 7 - Mid Anterior | -0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 11 - Mid Inferolateral | 0.000 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 1 - Basal Anterior | -0.118 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 6 - Basal Anterolateral | -0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 2: Segment 2 - Basal Anteroseptal | -0.176 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 1: Segment 2 - Basal Anteroseptal | 0.059 Difference of scores |
| Flurpiridaz (18F): SPE vs. HPLC | Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process | Reader 3: Segment 5 - Basal Inferolateral | 0.235 Difference of scores |
Secondary
Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Difference was calculated by (Mean SUV from the second injection - Mean SUV from the first injection). SUV was calculated as Decay Corrected Uptake (kBq/cc) / (Injected Dose \[MBq\] / Weight (kilogram \[kg\]). Difference in SUV of TACs by region after MPI sessions using 2 Flurpiridaz (18F) injection doses synthesized by same and 2 different manufacturing processes was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, overall number of participants analyzed was the number of participants in MITT population for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferior | 1.582 percent | Standard Deviation 0.6831 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Liver | 1.208 percent | Standard Deviation 0.6282 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Lung | 1.652 percent | Standard Deviation 0.8 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterior | 1.218 percent | Standard Deviation 0.8081 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anteroseptal | 1.587 percent | Standard Deviation 0.8049 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferoseptal | 1.839 percent | Standard Deviation 0.7109 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Blood | 2.445 percent | Standard Deviation 1.3493 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferolateral | 1.429 percent | Standard Deviation 0.7059 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterolateral | 1.477 percent | Standard Deviation 0.6315 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterior | 1.715 percent | Standard Deviation 1.1142 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anteroseptal | 1.882 percent | Standard Deviation 1.0797 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferoseptal | 2.085 percent | Standard Deviation 0.9045 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferior | 2.132 percent | Standard Deviation 0.9901 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferolateral | 1.815 percent | Standard Deviation 0.8898 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterolateral | 1.847 percent | Standard Deviation 0.9456 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Anterior | 1.641 percent | Standard Deviation 0.9567 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Septal | 1.669 percent | Standard Deviation 0.9274 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Inferior | 2.037 percent | Standard Deviation 0.7632 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Lateral | 1.675 percent | Standard Deviation 1.0117 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apex | 1.424 percent | Standard Deviation 0.7731 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Anterior Descending Artery (LAD) | 1.357 percent | Standard Deviation 0.9189 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Circumflex Artery (LCX) | 1.503 percent | Standard Deviation 0.759 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Right Coronary Artery (RCA) | 1.846 percent | Standard Deviation 0.7726 |
| Flurpiridaz (18F): SPE | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Whole Myocardium | 1.449 percent | Standard Deviation 0.7983 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Circumflex Artery (LCX) | 1.194 percent | Standard Deviation 0.5908 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Blood | 1.677 percent | Standard Deviation 0.6376 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferior | 1.564 percent | Standard Deviation 1.33 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Septal | 1.382 percent | Standard Deviation 1.1146 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Liver | 0.994 percent | Standard Deviation 0.7682 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anteroseptal | 1.235 percent | Standard Deviation 0.7855 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Anterior Descending Artery (LAD) | 1.065 percent | Standard Deviation 0.7425 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Lung | 1.507 percent | Standard Deviation 1.3117 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferolateral | 1.387 percent | Standard Deviation 0.9522 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Right Coronary Artery (RCA) | 1.319 percent | Standard Deviation 0.8727 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterior | 1.418 percent | Standard Deviation 0.7167 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterior | 1.322 percent | Standard Deviation 0.9838 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Inferior | 1.312 percent | Standard Deviation 0.9 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anteroseptal | 1.432 percent | Standard Deviation 0.6574 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterolateral | 1.408 percent | Standard Deviation 1.1032 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferoseptal | 1.538 percent | Standard Deviation 1.0105 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferoseptal | 1.490 percent | Standard Deviation 0.5679 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterolateral | 1.612 percent | Standard Deviation 0.7959 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Whole Myocardium | 1.100 percent | Standard Deviation 0.7513 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferior | 1.365 percent | Standard Deviation 0.8715 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Anterior | 0.897 percent | Standard Deviation 0.575 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Lateral | 1.094 percent | Standard Deviation 0.7583 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferolateral | 1.467 percent | Standard Deviation 0.59 |
| Flurpiridaz (18F): HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apex | 1.105 percent | Standard Deviation 0.8259 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferolateral | 2.187 percent | Standard Deviation 2.5969 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterolateral | 2.390 percent | Standard Deviation 2.7995 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterior | 2.409 percent | Standard Deviation 2.8687 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anteroseptal | 2.450 percent | Standard Deviation 2.8654 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apex | 1.833 percent | Standard Deviation 1.9528 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferoseptal | 2.330 percent | Standard Deviation 2.685 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Right Coronary Artery (RCA) | 2.052 percent | Standard Deviation 2.4344 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferior | 2.211 percent | Standard Deviation 2.6039 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferolateral | 2.511 percent | Standard Deviation 3.1065 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Anterior Descending Artery (LAD) | 2.102 percent | Standard Deviation 2.6262 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterolateral | 2.605 percent | Standard Deviation 3.2431 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Whole Myocardium | 2.052 percent | Standard Deviation 2.7089 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Anterior | 2.286 percent | Standard Deviation 2.6271 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Blood | 2.097 percent | Standard Deviation 1.2356 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Liver | 1.635 percent | Standard Deviation 1.6405 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Septal | 2.014 percent | Standard Deviation 2.3986 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Lung | 1.110 percent | Standard Deviation 1.2815 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Circumflex Artery (LCX) | 2.248 percent | Standard Deviation 2.9416 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterior | 2.390 percent | Standard Deviation 2.7086 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anteroseptal | 2.747 percent | Standard Deviation 2.8378 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Inferior | 1.986 percent | Standard Deviation 2.161 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferoseptal | 2.439 percent | Standard Deviation 2.559 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferior | 2.144 percent | Standard Deviation 2.3601 |
| Flurpiridaz (18F): SPE vs. HPLC | Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Lateral | 2.434 percent | Standard Deviation 2.7838 |
Secondary
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
Image quality scoring was performed as following: SPE image was worse than HPLC image when the difference (SPE - HPLC) score was less than or equal (\<=)-3. SPE image was slightly worse than HPTC image when the difference score was \<=-1 and greater than (\>)-3. SPE and HPLC images were the same when the difference score was \>-1 and less than (\<) 1. SPE image was slightly better when the difference score \>=1 and \<3. SPE image was better when the difference was \>=3. Higher score indicates better outcomes. Number of participants categorized based on intra-reader agreement of the image quality score between the 2 Sets of PET images for 2 Flurpiridaz (18F) injection doses from different manufacturing processes was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, overall number of participants analyzed was the number of participants in MITT population for each treatment group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 1 | SPE image was worse than HPLC image | 1 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 1 | SPE image was slightly worse than HPLC image | 3 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 1 | SPE and HPLC images were the same | 11 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 1 | SPE image was slightly better than HPLC image | 2 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 1 | SPE image was better than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 2 | SPE image was worse than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 2 | SPE image was slightly worse than HPLC image | 1 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 2 | SPE and HPLC images were the same | 16 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 2 | SPE image was slightly better than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 2 | SPE image was better than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 3 | SPE image was worse than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 3 | SPE image was slightly worse than HPLC image | 3 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 3 | SPE and HPLC images were the same | 13 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 3 | SPE image was slightly better than HPLC image | 1 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Perfusion Image Quality: Reader 3 | SPE image was better than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 1 | SPE image was worse than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 1 | SPE image was slightly worse than HPLC image | 5 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 1 | SPE and HPLC images were the same | 9 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 1 | SPE image was slightly better than HPLC image | 3 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 1 | SPE image was better than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 2 | SPE image was worse than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 2 | SPE image was slightly worse than HPLC image | 3 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 2 | SPE and HPLC images were the same | 12 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 2 | SPE image was slightly better than HPLC image | 2 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 2 | SPE image was better than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 3 | SPE image was worse than HPLC image | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 3 | SPE image was slightly worse than HPLC image | 6 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 3 | SPE and HPLC images were the same | 8 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 3 | SPE image was slightly better than HPLC image | 3 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes | Gated Image Quality: Reader 3 | SPE image was better than HPLC image | 0 Participants |
Secondary
Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
Image quality scoring was performed as following: 2 images were the same when the absolute difference score was \>=0 and \<1. 2 images were slightly different when the absolute difference score \>=1 and \<3. 2 images were different when the absolute difference score \>=3. Higher score indicates better outcomes. Number of participants categorized based on intra-reader agreement of the image quality score between the 2 sets of PET Images for 2 Flurpiridaz (18F) injection doses from same manufacturing processes was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. Here, overall number of participants analyzed was the number of participants in MITT population for each treatment group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 1 | 2 images were the same | 4 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 1 | 2 images were slightly different | 3 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 1 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 2 | 2 images were the same | 7 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 2 | 2 images were slightly different | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 2 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 3 | 2 images were the same | 5 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 3 | 2 images were slightly different | 2 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 3 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 1 | 2 images were the same | 4 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 1 | 2 images were slightly different | 3 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 1 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 2 | 2 images were the same | 6 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 2 | 2 images were slightly different | 1 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 2 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 3 | 2 images were the same | 6 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 3 | 2 images were slightly different | 1 Participants |
| Flurpiridaz (18F): SPE | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 3 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 2 | 2 images were slightly different | 1 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 1 | 2 images were the same | 3 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 1 | 2 images were the same | 4 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 1 | 2 images were slightly different | 3 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 3 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 1 | 2 images were different | 1 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 1 | 2 images were slightly different | 3 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 2 | 2 images were the same | 7 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 2 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 2 | 2 images were slightly different | 0 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 1 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 2 | 2 images were different | 0 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 3 | 2 images were slightly different | 4 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 3 | 2 images were the same | 5 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 2 | 2 images were the same | 6 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 3 | 2 images were slightly different | 2 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Gated Image Quality: Reader 3 | 2 images were the same | 3 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes | Perfusion Image Quality: Reader 3 | 2 images were different | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
A TEAE was defined as an adverse events (AE) that occurred from the time of investigational medicinal product (IMP) administration through the end of the follow-up period for the corresponding dose. Any medication error, clinically significant vital signs, electrocardiograms (ECGs), hematology, clinical chemistry laboratory tests, and urinalysis values determined by investigator were reported as TEAEs. Number of participants with TEAEs and serious TEAEs were reported.
Time frame: From screening up to end of follow up (up to 30 days)
Population: The Safety Population included all participants who received \>=1 dose of Flurpiridaz (18F) Injection in the study. Here, overall number of participants analyzed signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Flurpiridaz (18F): SPE | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 3 Participants |
| Flurpiridaz (18F): SPE | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 1 Participants |
| Flurpiridaz (18F): HPLC | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
Secondary
Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses
Percentage of participants with intra-reader agreement of the detected ischemic defect on PET-MPI was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, overall number of participants analyzed was the number of participants in MITT population for each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz (18F): SPE | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 2 | 85.7 percentage of participants |
| Flurpiridaz (18F): SPE | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 1 | 100.0 percentage of participants |
| Flurpiridaz (18F): SPE | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 3 | 100.0 percentage of participants |
| Flurpiridaz (18F): HPLC | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 2 | 100.0 percentage of participants |
| Flurpiridaz (18F): HPLC | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 1 | 71.4 percentage of participants |
| Flurpiridaz (18F): HPLC | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 3 | 100.0 percentage of participants |
| Flurpiridaz (18F): SPE vs. HPLC | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 1 | 94.1 percentage of participants |
| Flurpiridaz (18F): SPE vs. HPLC | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 3 | 94.1 percentage of participants |
| Flurpiridaz (18F): SPE vs. HPLC | Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses | Reader 2 | 94.1 percentage of participants |
Comparison: Reader 195% CI: [1, 1]
Comparison: Reader 295% CI: [0.1696, 1]
Comparison: Reader 395% CI: [1, 1]
Comparison: Reader 195% CI: [-0.0699, 0.993]
Comparison: Reader 295% CI: [1, 1]
Comparison: Reader 395% CI: [1, 1]
Comparison: Reader 195% CI: [0.6567, 1]
Comparison: Reader 295% CI: [0.6614, 1]
Comparison: Reader 395% CI: [0.6567, 1]
Secondary
Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
Relative difference was calculated as 100 (SUV1-SUV2) / (0.5\*\[SUV1 + SUV2\]) and SUV was calculated as Decay Corrected Uptake (kBq/cc) / (Injected Dose \[MBq\] / Weight \[kg\]). Relative difference in SUV of TACs by region after MPI sessions using 2 Flurpiridaz (18F) injection doses synthesized by same and 2 different manufacturing processes was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, overall number of participants analyzed was the number of participants in MITT population for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferior | 3.199 percent | Standard Deviation 13.1457 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Liver | 5.965 percent | Standard Deviation 25.598 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Lung | -2.647 percent | Standard Deviation 34.8133 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterior | -1.991 percent | Standard Deviation 10.5622 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anteroseptal | 1.031 percent | Standard Deviation 10.6386 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferoseptal | 7.157 percent | Standard Deviation 18.2437 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Blood | 0.738 percent | Standard Deviation 27.4693 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferolateral | 2.525 percent | Standard Deviation 14.196 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterolateral | 0.007 percent | Standard Deviation 15.6644 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterior | 0.591 percent | Standard Deviation 17.8879 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anteroseptal | 4.007 percent | Standard Deviation 15.5683 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferoseptal | 4.716 percent | Standard Deviation 17.7702 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferior | 8.081 percent | Standard Deviation 21.0838 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferolateral | 6.665 percent | Standard Deviation 15.4194 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterolateral | 3.024 percent | Standard Deviation 17.5448 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Anterior | 6.649 percent | Standard Deviation 18.1637 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Septal | 5.473 percent | Standard Deviation 17.0274 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Inferior | 1.624 percent | Standard Deviation 20.8841 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Lateral | 2.404 percent | Standard Deviation 15.9485 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apex | 5.073 percent | Standard Deviation 17.2269 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Anterior Descending Artery (LAD) | 2.088 percent | Standard Deviation 13.6375 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Circumflex Artery (LCX) | 2.883 percent | Standard Deviation 14.1203 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Right Coronary Artery (RCA) | 3.205 percent | Standard Deviation 16.88 |
| Flurpiridaz (18F): SPE | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Whole Myocardium | 2.818 percent | Standard Deviation 14.3881 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anteroseptal | -7.183 percent | Standard Deviation 13.648 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Blood | 2.500 percent | Standard Deviation 32.0112 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferior | -14.493 percent | Standard Deviation 30.8501 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Septal | -6.934 percent | Standard Deviation 18.1451 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Liver | -2.200 percent | Standard Deviation 21.772 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterior | -12.036 percent | Standard Deviation 16.6875 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Anterior Descending Artery (LAD) | -7.123 percent | Standard Deviation 13.8785 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Lung | -10.949 percent | Standard Deviation 35.3666 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferolateral | -12.251 percent | Standard Deviation 21.768 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterolateral | -11.312 percent | Standard Deviation 18.2771 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterior | -9.725 percent | Standard Deviation 17.1715 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Whole Myocardium | -8.226 percent | Standard Deviation 14.2067 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Inferior | -8.174 percent | Standard Deviation 15.6239 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anteroseptal | -5.606 percent | Standard Deviation 20.6948 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterolateral | -10.975 percent | Standard Deviation 14.4678 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferoseptal | -12.442 percent | Standard Deviation 23.8374 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferoseptal | -4.976 percent | Standard Deviation 19.2974 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Circumflex Artery (LCX) | -8.554 percent | Standard Deviation 13.5718 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Right Coronary Artery (RCA) | -9.506 percent | Standard Deviation 18.8804 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferior | -12.323 percent | Standard Deviation 21.9242 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Anterior | -3.935 percent | Standard Deviation 10.0975 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Lateral | -2.015 percent | Standard Deviation 12.7979 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferolateral | -14.008 percent | Standard Deviation 22.3971 |
| Flurpiridaz (18F): HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apex | -0.038 percent | Standard Deviation 15.2867 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferolateral | -2.293 percent | Standard Deviation 15.4717 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterolateral | 6.782 percent | Standard Deviation 12.5498 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Right Coronary Artery (RCA) | -0.584 percent | Standard Deviation 15.3095 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterior | 3.186 percent | Standard Deviation 12.8762 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anteroseptal | 0.789 percent | Standard Deviation 13.9519 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apex | -2.059 percent | Standard Deviation 11.0612 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferoseptal | -0.140 percent | Standard Deviation 14.7096 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Anterior Descending Artery (LAD) | 1.212 percent | Standard Deviation 12.286 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferior | -0.601 percent | Standard Deviation 16.8102 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Inferolateral | -1.414 percent | Standard Deviation 18.0348 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Mid Anterolateral | 2.994 percent | Standard Deviation 13.519 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Anterior | 1.708 percent | Standard Deviation 12.9038 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Left Circumflex Artery (LCX) | -0.344 percent | Standard Deviation 15.0979 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Blood | -12.260 percent | Standard Deviation 22.1399 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Liver | -6.042 percent | Standard Deviation 24.0731 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Septal | 0.802 percent | Standard Deviation 13.5151 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Lung | 9.030 percent | Standard Deviation 39.7082 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Whole Myocardium | 0.577 percent | Standard Deviation 13.2035 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anterior | 3.246 percent | Standard Deviation 13.6798 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Anteroseptal | -2.130 percent | Standard Deviation 16.5611 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Inferior | -2.135 percent | Standard Deviation 16.0488 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferoseptal | 1.540 percent | Standard Deviation 16.5447 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Basal Inferior | 0.060 percent | Standard Deviation 17.9617 |
| Flurpiridaz (18F): SPE vs. HPLC | Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes | Apical Lateral | 0.133 percent | Standard Deviation 17.6721 |
Secondary
Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process
Variability of SRS was estimated by using the SD of the paired difference divided by square root of 2. SRS was used for myocardial perfusion defects examination. The independent reads of all MPI images were based on standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Variability of the SRS after MPI sessions using 2 Flurpiridaz (18F) injection doses by the same process was reported.
Time frame: Up to 2 weeks
Population: Analysis was performed on mITT population. Here, overall number of participants analyzed signifies the participants with non-missing values receiving 2 doses with the same manufacturing process (either SPE-SPE or HPLC-HPLC). A participant received SPE in both periods was counted twice in SPE group and a participant received HPLC in both periods was counted twice in HPLC group, while a participant received both methods was counted once in each group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz (18F): SPE | Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process | Reader 1 | 0.35 (units on a scale)/(square root 2) |
| Flurpiridaz (18F): SPE | Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process | Reader 2 | 2.67 (units on a scale)/(square root 2) |
| Flurpiridaz (18F): SPE | Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process | Reader 3 | 1.07 (units on a scale)/(square root 2) |
| Flurpiridaz (18F): HPLC | Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process | Reader 1 | 3.20 (units on a scale)/(square root 2) |
| Flurpiridaz (18F): HPLC | Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process | Reader 2 | 2.06 (units on a scale)/(square root 2) |
| Flurpiridaz (18F): HPLC | Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process | Reader 3 | 3.67 (units on a scale)/(square root 2) |