Dynamic PET/CT Imaging
Conditions
Brief summary
The goal of this study is to see how the images collected during the first hour compare with the routine images collected as part of the clinical scan.
Interventions
DEVICEDynamic PET/CT Imaging
-Will take approximately 60 minutes
Sponsors
Siemens Corporation, Corporate Technology
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Cohort: * 18 years of age or older * Scheduled to undergo a clinical PET/CT scan with any clinically prescribed radiotracer for known or suspected malignancy (pathologic confirmation not required) * Able to provide informed consent Inclusion Criteria Repeatability Cohort: * 18 years of age or older * Scheduled to undergo a clinical PET/CT FDG or 68Ga- DOTA-0-Tyr3-Octreotate (DOTATATE) for known or suspected malignancy (pathologic confirmation not required) * Able to provide informed consent
Exclusion criteria
-Younger than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Rapid, Whole-body Dynamic PET Imaging as Measured by Number of Participants Who Successfully Completed the Study Imaging Component | At time of scan (day 1) | -Successful completion of the study imaging component will be defined as: (1) patient remains on scanner for the full dynamic phase of PET imaging prior to the standard of care PET/CT and (2) automated scanner software is able to successfully generate valid parametric maps (requires at least three consecutive whole-body PET acquisitions without substantial motion between acquisitions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs) | At the time of scan (Day 1) | Subjects underwent standard-of-care (SOC) PET acquisition with a respiratory-gating belt. Ungated (UG), belt-gating-derived optimal gate (BG-OG), EMCD utilizing belt gating (BG-EMCD), and EMCD utilizing data-driven gating (DDG-EMCD) images were reconstructed. Tracer-avid lesions in the lower chest or upper abdomen were segmented. Quantitative metrics were extracted. |
| Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate | At the time of scan (Day 1) | * Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise. |
| Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Belt Gating | At the time of scan (Day 1) | * Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise. |
| Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | At the time of scan (Day 1) | * Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise. |
| Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Belt Gating | At the time of scan (Day 1) | * Will be assessed by Reader 1 and Reader 2 comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise. |
| Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max | At the time of scan (Day 1) | Subjects underwent standard-of-care (SOC) PET acquisition with a respiratory-gating belt. Ungated (UG), belt-gating-derived optimal gate (BG-OG), EMCD utilizing belt gating (BG-EMCD), and EMCD utilizing data-driven gating (DDG-EMCD) images were reconstructed. Tracer-avid lesions in the lower chest or upper abdomen were segmented. Quantitative metrics were extracted. |
| Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Elastic Motion Correction With Blurring Utilizing Belt Gating and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | At the time of scan (Day 1) | * Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise. |
| Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | Day 1 and approximately 1 week later | * Standardized uptake value (SUV)-max, SUV-peak, Uptake time-corrected SUV (cSUV), Standardized uptake ratio (SUR), Uptake time-corrected standardized uptake ratio (cSUR), Patlak slope (PS)-max, and PS-peak were analyzed. * Test-retest repeatability of quantitative metrics based on the PS versus the SUV among lesions and normal organs on oncologic \[18F\]FDG-PET/CT. * Repeatability was assessed via mean test-retest percent changes \[T-RT %Δ\] |
| Metabolic Rate of Images | At the time of scan (Day 1) | -Will help to determine the optimal post-injection time period for dynamic PET imaging for Early (35-50 min post-injection) and Late (75-90 min post-injection) Patlak slope (PS) analysis. Reader 1 and Reader 2 used a standard Likert score from 0-4 with 1 being the worst and 4 being the best. A higher score indicated the image was easier to read. |
| Volume of Distribution (Intercept) Images | At the time of scan (Day 1) | -Will help to determine the optimal post-injection time period for dynamic PET imaging for Patlak analysis. |
| Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | At the time of scan (Day 1) | * Will be assessed Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dynamic PET Imaging * Dynamic PET/CT imaging will begin at approximately the same time as the clinically prescribed radiotracer injection and will continue until approximately the start of the clinical scan
* A subset of patients (up to 30 scheduled to undergo FDG or DOTATATE PET/CT imaging) will be asked to return within 7 days for a repeat imaging study. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Dynamic PET Imaging |
|---|---|
| Age, Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 75 Participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 1 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Primary
Feasibility of Rapid, Whole-body Dynamic PET Imaging as Measured by Number of Participants Who Successfully Completed the Study Imaging Component
-Successful completion of the study imaging component will be defined as: (1) patient remains on scanner for the full dynamic phase of PET imaging prior to the standard of care PET/CT and (2) automated scanner software is able to successfully generate valid parametric maps (requires at least three consecutive whole-body PET acquisitions without substantial motion between acquisitions).
Time frame: At time of scan (day 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dynamic PET Imaging | Feasibility of Rapid, Whole-body Dynamic PET Imaging as Measured by Number of Participants Who Successfully Completed the Study Imaging Component | 80 Participants |
Secondary
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Belt Gating
* Will be assessed by Reader 1 and Reader 2 comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.
Time frame: At the time of scan (Day 1)
Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Belt Gating | Reader 1 | 0.14 mean relative lesion number |
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Belt Gating | Reader 2 | 0.14 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Belt Gating | Reader 1 | 1.28 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Belt Gating | Reader 2 | 0.50 mean relative lesion number |
Comparison: This is the statistical analysis for Reader 1.p-value: <0.001Two-tailed Wilcoxon signed-rank test.
Comparison: This is the statistical analysis for Reader 2.p-value: 0.02Two-tailed Wilcoxon signed-rank test.
Secondary
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Data-driven Gating
* Will be assessed Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.
Time frame: At the time of scan (Day 1)
Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 2 | 0.14 mean relative lesion number |
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 1 | 0.14 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 1 | 1.47 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 2 | 0.50 mean relative lesion number |
Comparison: This is the statistical analysis for Reader 1.p-value: <0.001Two-tailed Wilcoxon signed-rank test.
Comparison: This is the statistical analysis for Reader 2.p-value: 0.02Two-tailed Wilcoxon signed-rank test.
Secondary
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Elastic Motion Correction With Blurring Utilizing Belt Gating and Elastic Motion Correction With Blurring Utilizing Data-driven Gating
* Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.
Time frame: At the time of scan (Day 1)
Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Elastic Motion Correction With Blurring Utilizing Belt Gating and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 1 | 1.28 mean relative lesion number |
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Elastic Motion Correction With Blurring Utilizing Belt Gating and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 2 | 0.50 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Elastic Motion Correction With Blurring Utilizing Belt Gating and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 1 | 1.47 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Elastic Motion Correction With Blurring Utilizing Belt Gating and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 2 | 1.47 mean relative lesion number |
Secondary
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate
* Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.
Time frame: At the time of scan (Day 1)
Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate | Reader 1 | 1.11 relative lesions |
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate | Reader 2 | 0.31 relative lesions |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate | Reader 1 | 0.14 relative lesions |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate | Reader 2 | 0.14 relative lesions |
Comparison: This statistical analysis is for Reader 1.p-value: 0.001Two-tailed Wildoxon signed-rank test
Comparison: This statistical analysis is for Reader 2.p-value: 0.28Two-tailed Wilcoxon signed-rank test
Secondary
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Belt Gating
* Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.
Time frame: At the time of scan (Day 1)
Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Belt Gating | Reader 1 | 1.11 mean relative lesion number |
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Belt Gating | Reader 2 | 0.31 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Belt Gating | Reader 1 | 1.28 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Belt Gating | Reader 2 | 0.50 mean relative lesion number |
Comparison: This is the statistical analysis for Reader 1.p-value: 0.22Two-tailed Wilcoxon signed-rank test.
Comparison: This is the statistical analysis for Reader 2.p-value: >0.05Two-tailed Wilcoxon signed-rank test.
Secondary
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Data-driven Gating
* Will be assessed by Reader 1 and Reader 2 by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. * OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.
Time frame: At the time of scan (Day 1)
Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 1 | 1.11 mean relative lesion number |
| Dynamic PET Imaging | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 2 | 0.31 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 1 | 1.47 mean relative lesion number |
| Dynamic PET/CT Belt-Gating Optimal Gate | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Data-driven Gating | Reader 2 | 0.50 mean relative lesion number |
Comparison: This is the statistical analysis for Reader 1.p-value: 0.009Two-tailed Wilcoxon signed-rank test.
Comparison: This statistical analysis is for Reader 2.p-value: >0.05Two-tailed Wilcoxon signed-rank test.
Secondary
Metabolic Rate of Images
-Will help to determine the optimal post-injection time period for dynamic PET imaging for Early (35-50 min post-injection) and Late (75-90 min post-injection) Patlak slope (PS) analysis. Reader 1 and Reader 2 used a standard Likert score from 0-4 with 1 being the worst and 4 being the best. A higher score indicated the image was easier to read.
Time frame: At the time of scan (Day 1)
Population: This outcome measure required subjects to have cancer so only 41 subjects had sufficient cancer in order to be analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dynamic PET Imaging | Metabolic Rate of Images | PS-Early Reader 2 | 2.14 score on a scale |
| Dynamic PET Imaging | Metabolic Rate of Images | PS-Late Reader 2 | 3.95 score on a scale |
| Dynamic PET Imaging | Metabolic Rate of Images | PS-Early Reader 1 | 1.19 score on a scale |
| Dynamic PET Imaging | Metabolic Rate of Images | PS-Late Reader 1 | 3.95 score on a scale |
Comparison: This is the statistical analysis comparing PS-Early Reader 1 to PS-Late Reader 1.p-value: <0.001Two-tailed Wilcoxon signed-rank test.
Comparison: This is the statistical analysis comparing PS-Early Reader 2 and PS-Late Reader 2.p-value: <0.001Two-tailed Wilcoxon signed-rank test.
Secondary
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs)
Subjects underwent standard-of-care (SOC) PET acquisition with a respiratory-gating belt. Ungated (UG), belt-gating-derived optimal gate (BG-OG), EMCD utilizing belt gating (BG-EMCD), and EMCD utilizing data-driven gating (DDG-EMCD) images were reconstructed. Tracer-avid lesions in the lower chest or upper abdomen were segmented. Quantitative metrics were extracted.
Time frame: At the time of scan (Day 1)
Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dynamic PET Imaging | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs) | Belt-gating optimal gate | 6.31 contrast-to-noise ratio |
| Dynamic PET Imaging | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs) | Elastic motion correction with blurring utilizing belt gating | 9.14 contrast-to-noise ratio |
| Dynamic PET Imaging | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs) | Elastic motion correction with blurring utilizing data-driven gating | 8.89 contrast-to-noise ratio |
| Dynamic PET Imaging | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs) | Ungated | 7.89 contrast-to-noise ratio |
Secondary
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max
Subjects underwent standard-of-care (SOC) PET acquisition with a respiratory-gating belt. Ungated (UG), belt-gating-derived optimal gate (BG-OG), EMCD utilizing belt gating (BG-EMCD), and EMCD utilizing data-driven gating (DDG-EMCD) images were reconstructed. Tracer-avid lesions in the lower chest or upper abdomen were segmented. Quantitative metrics were extracted.
Time frame: At the time of scan (Day 1)
Population: This outcome measure requires subjects to have disease so only 36 subjects had disease.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dynamic PET Imaging | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max | Belt-gating optimal gate | 10.77 SUV-max |
| Dynamic PET Imaging | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max | Elastic motion correction with blurring utilizing belt gating | 10.75 SUV-max |
| Dynamic PET Imaging | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max | Elastic motion correction with blurring utilizing data-driven gating | 10.74 SUV-max |
| Dynamic PET Imaging | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max | Ungated | 9.00 SUV-max |
Secondary
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
* Standardized uptake value (SUV)-max, SUV-peak, Uptake time-corrected SUV (cSUV), Standardized uptake ratio (SUR), Uptake time-corrected standardized uptake ratio (cSUR), Patlak slope (PS)-max, and PS-peak were analyzed. * Test-retest repeatability of quantitative metrics based on the PS versus the SUV among lesions and normal organs on oncologic \[18F\]FDG-PET/CT. * Repeatability was assessed via mean test-retest percent changes \[T-RT %Δ\]
Time frame: Day 1 and approximately 1 week later
Population: Only 9 subjects completed the test-retest protocol and of those only 4 subjects had \[18F\]FDG-avid lesions.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | PS-peak | 15 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | SUV-max | 47 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | SUV-peak | 26 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | SUR-max | 81 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | PS-max | 11 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | cSUV-max | -6 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | cSUV-peak | -27 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | SUR-peak | 63 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | cSUR-max | 7 test-retest percent changes |
| Dynamic PET Imaging | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | cSUR-peak | -14 test-retest percent changes |
Secondary
Volume of Distribution (Intercept) Images
-Will help to determine the optimal post-injection time period for dynamic PET imaging for Patlak analysis.
Time frame: At the time of scan (Day 1)
Population: The intercept images were unacceptable due to high quantitative biases and noise levels.