Alzheimer Disease
Conditions
Brief summary
The purpose of this study is to evaluate the biodistribution, safety and tolerability of a single dose of \[18F\]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese participants.
Interventions
DIAGNOSTIC_TEST[18F]GTP1
\[18F\]GTP1 IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie \[mCi\]), with a maximum drug mass dose of 10 microgram (μg).
Sponsors
Invicro
Genentech, Inc.
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
Yes
Inclusion criteria
Key inclusion criteria: * Healthy with no clinically relevant finding on physical examination at screening and prior to radiopharmaceutical administration * Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 30 days after the final dose * Male participants with partners of childbearing potential must commit to the use of two methods of contraception for the study duration and 90 days after the last dose * Male participants must not donate sperm for the duration of the study and 90 days after the last dose * Participants must have both Japanese parents and all Japanese grandparents Key
Exclusion criteria
* Participants with any significant medical disorder or disease expected to interfere with the study * Current or prior history (within a six-month period) of exposure to nicotine products * History of drug or alcohol abuse within 12 months prior to screening * Prior participation in other research protocols or clinical care in the last year, such that radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSv), the allowable annual limit for research participants as established by the US Federal Guidelines * Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing * Use of over the counter (OTC) medication, dietary supplements, or vitamins, within 2 weeks prior to initial dosing * Known hypersensitivity to any component of the formulation of \[18F\]GTP1 or related compounds * Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing * History of immunodeficiency diseases, including positive human immunodeficiency virus (HIV) test * Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody * Women who are pregnant, lactating or breastfeeding * Unsuitable veins for repeated venipuncture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Day 1 | Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID). |
| Source Organ Residence Time (Total Number of Disintegrations) | Day 1 | Source organ uptake and washout with calculation of total number of disintegrations (or residence time, or kinetic values) using the area under the time-activity curve divided by the injected dose of radiopharmaceutical |
| Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Day 1 | Radiation absorbed dose estimates based on the Medical Internal Radiation Dose (MIRD) methodology utilizing urine data and International Commission on Radiological Protection (ICRP) gastrointestinal (GI) tract kinetics |
| Percentage of Participants With Adverse Events | Up to 5 days | An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition, even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation during any phase of the study. Medical conditions/diseases present before starting study drug are only considered AEs if they worsen after starting study drug. Abnormal laboratory values or test results constitute AEs only if they induce clinical signs or symptoms, are considered clinically significant, or require therapy. |
Countries
United States
Participant flow
Recruitment details
Screening assessments were completed within 30 days of Day 1.
Participants by arm
| Arm | Count |
|---|---|
| [18F]GTP1 Participants received a single bolus injection of radioligand \[18F\]GTP1 intravenously (IV). | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | [18F]GTP1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 51.33 Years STANDARD_DEVIATION 15.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
| Weight | 55.32 Kg STANDARD_DEVIATION 11.29 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology
Radiation absorbed dose estimates based on the Medical Internal Radiation Dose (MIRD) methodology utilizing urine data and International Commission on Radiological Protection (ICRP) gastrointestinal (GI) tract kinetics
Time frame: Day 1
Population: Testes not analyzed for female population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Stomach Wall | 0.0141 mSv/MBq | Standard Deviation 0.000929 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Ovaries | 0.0276 mSv/MBq | Standard Deviation 0.00133 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Gallbladder Wall | 0.0756 mSv/MBq | Standard Deviation 0.0662 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Pancreas | 0.0167 mSv/MBq | Standard Deviation 0.0015 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | ULI Wall | 0.127 mSv/MBq | Standard Deviation 0.00513 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Red Marrow | 0.0104 mSv/MBq | Standard Deviation 0.000636 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Adrenals | 0.0164 mSv/MBq | Standard Deviation 0.00156 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Osteogenic Cells | 0.0107 mSv/MBq | Standard Deviation 0.00161 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Heart Wall | 0.0196 mSv/MBq | Standard Deviation 0.00309 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Skin | 0.0055 mSv/MBq | Standard Deviation 0.000749 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | LLI Wall | 0.0447 mSv/MBq | Standard Deviation 0.00236 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Spleen | 0.0156 mSv/MBq | Standard Deviation 0.00253 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Kidneys | 0.0429 mSv/MBq | Standard Deviation 0.0119 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Breasts | 0.00595 mSv/MBq | Standard Deviation 0.000974 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Thymus | 0.00667 mSv/MBq | Standard Deviation 0.00117 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Liver | 0.101 mSv/MBq | Standard Deviation 0.0183 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Thyroid | 0.00472 mSv/MBq | Standard Deviation 0.00107 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Small Intestine | 0.117 mSv/MBq | Standard Deviation 0.00513 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Urinary Bladder Wall | 0.129 mSv/MBq | Standard Deviation 0.0472 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Lungs | 0.0145 mSv/MBq | Standard Deviation 0.000833 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Uterus | 0.0258 mSv/MBq | Standard Deviation 0.00225 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Brain | 0.00789 mSv/MBq | Standard Deviation 0.00075 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Total Body | 0.0134 mSv/MBq | Standard Deviation 0.000808 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Effective dose (ED, ICRP-60) | 0.0303 mSv/MBq | Standard Deviation 0.0008 |
| [18F]GTP1 | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Muscle | 0.0093 mSv/MBq | Standard Deviation 0.000663 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Total Body | 0.0103 mSv/MBq | Standard Deviation 0.000552 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Effective dose (ED, ICRP-60) | 0.0245 mSv/MBq | Standard Deviation 0.000436 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Adrenals | 0.0123 mSv/MBq | Standard Deviation 0.000451 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Brain | 0.00606 mSv/MBq | Standard Deviation 0.00132 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Breasts | 0.00457 mSv/MBq | Standard Deviation 0.00044 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Gallbladder Wall | 0.0713 mSv/MBq | Standard Deviation 0.0353 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | LLI Wall | 0.0376 mSv/MBq | Standard Deviation 0.00314 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Small Intestine | 0.0925 mSv/MBq | Standard Deviation 0.00864 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Stomach Wall | 0.0106 mSv/MBq | Standard Deviation 0.000758 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | ULI Wall | 0.105 mSv/MBq | Standard Deviation 0.00974 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Heart Wall | 0.0167 mSv/MBq | Standard Deviation 0.00439 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Kidneys | 0.037 mSv/MBq | Standard Deviation 0.00705 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Liver | 0.0702 mSv/MBq | Standard Deviation 0.0034 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Lungs | 0.0138 mSv/MBq | Standard Deviation 0.00191 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Muscle | 0.00732 mSv/MBq | Standard Deviation 0.000499 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Ovaries | 0.0216 mSv/MBq | Standard Deviation 0.00379 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Pancreas | 0.0128 mSv/MBq | Standard Deviation 0.000379 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Red Marrow | 0.00841 mSv/MBq | Standard Deviation 0.000637 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Osteogenic Cells | 0.00787 mSv/MBq | Standard Deviation 0.000946 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Skin | 0.00428 mSv/MBq | Standard Deviation 0.000441 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Spleen | 0.0133 mSv/MBq | Standard Deviation 0.00313 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Testes | 0.00606 mSv/MBq | Standard Deviation 0.000261 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Thymus | 0.00513 mSv/MBq | Standard Deviation 0.00064 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Thyroid | 0.00388 mSv/MBq | Standard Deviation 0.00064 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Urinary Bladder Wall | 0.112 mSv/MBq | Standard Deviation 0.0198 |
| [18F]GTP1 Male | Mean Radiation Absorbed Dose Estimates in Target Organs and Whole Body Based on Standard Medical Internal Radiation Dose (MIRD) Methodology | Uterus | 0.0213 mSv/MBq | Standard Deviation 0.0007 |
Primary
Percentage of Participants With Adverse Events
An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition, even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation during any phase of the study. Medical conditions/diseases present before starting study drug are only considered AEs if they worsen after starting study drug. Abnormal laboratory values or test results constitute AEs only if they induce clinical signs or symptoms, are considered clinically significant, or require therapy.
Time frame: Up to 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| [18F]GTP1 | Percentage of Participants With Adverse Events | 1 Participants |
Primary
Source Organ Residence Time (Total Number of Disintegrations)
Source organ uptake and washout with calculation of total number of disintegrations (or residence time, or kinetic values) using the area under the time-activity curve divided by the injected dose of radiopharmaceutical
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Brain | 0.0375 MBq x hour/MBq | Standard Deviation 0.00295 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Gallbladder Contents | 0.0254 MBq x hour/MBq | Standard Deviation 0.038 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Gallbladder Contents with GB emptying model | 0.0102 MBq x hour/MBq | Standard Deviation 0.012 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | LLI Cont. | 0.0416 MBq x hour/MBq | Standard Deviation 0.00214 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | SI Cont. | 0.415 MBq x hour/MBq | Standard Deviation 0.0219 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | ULI Cont. | 0.228 MBq x hour/MBq | Standard Deviation 0.0117 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Heart Wall | 0.0153 MBq x hour/MBq | Standard Deviation 0.00326 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Kidneys | 0.046 MBq x hour/MBq | Standard Deviation 0.0195 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Liver | 0.591 MBq x hour/MBq | Standard Deviation 0.112 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Lungs | 0.0346 MBq x hour/MBq | Standard Deviation 0.00205 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Spleen | 0.00634 MBq x hour/MBq | Standard Deviation 0.00203 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Urinary Bladder Contents | 0.135 MBq x hour/MBq | Standard Deviation 0.047 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Urinary Bladder Contents with UB voiding model | 0.18 MBq x hour/MBq | Standard Deviation 0.0717 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Remainder | 0.743 MBq x hour/MBq | Standard Deviation 0.143 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Remainder with UB voiding model | 0.708 MBq x hour/MBq | Standard Deviation 0.181 |
| [18F]GTP1 | Source Organ Residence Time (Total Number of Disintegrations) | Remainder with both UB voiding and GB emptying models | 0.723 MBq x hour/MBq | Standard Deviation 0.161 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Remainder with both UB voiding and GB emptying models | 0.693 MBq x hour/MBq | Standard Deviation 0.12 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Brain | 0.0315 MBq x hour/MBq | Standard Deviation 0.00717 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Liver | 0.532 MBq x hour/MBq | Standard Deviation 0.0284 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Gallbladder Contents | 0.0304 MBq x hour/MBq | Standard Deviation 0.023 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Urinary Bladder Contents with UB voiding model | 0.222 MBq x hour/MBq | Standard Deviation 0.0441 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Gallbladder Contents with GB emptying model | 0.0122 MBq x hour/MBq | Standard Deviation 0.00637 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Lungs | 0.0523 MBq x hour/MBq | Standard Deviation 0.0125 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | LLI Cont. | 0.0396 MBq x hour/MBq | Standard Deviation 0.00401 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Remainder with UB voiding model | 0.675 MBq x hour/MBq | Standard Deviation 0.127 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | SI Cont. | 0.395 MBq x hour/MBq | Standard Deviation 0.0397 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Spleen | 0.0074 MBq x hour/MBq | Standard Deviation 0.00339 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | ULI Cont. | 0.217 MBq x hour/MBq | Standard Deviation 0.0219 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Remainder | 0.687 MBq x hour/MBq | Standard Deviation 0.056 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Heart Wall | 0.019 MBq x hour/MBq | Standard Deviation 0.00774 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Urinary Bladder Contents | 0.237 MBq x hour/MBq | Standard Deviation 0.0332 |
| [18F]GTP1 Male | Source Organ Residence Time (Total Number of Disintegrations) | Kidneys | 0.0448 MBq x hour/MBq | Standard Deviation 0.0114 |
Primary
Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs)
Decay corrected \[18F\]GTP1 time-activity in the source organs acquired following bolus tracer injection and expressed as %Injected Dose (ID).
Time frame: Day 1
Population: One participant was excluded from the analysis at mean collect times: 16.38604 and 32.41194 minutes due to power surge during the scan that caused the system to power off. The process to restart took \~20 min and the absence of these specific data points. There was no impact on the quality of the subsequent data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 5.32767 minutes | 0.33530 Percentage of Injected Dose | Standard Deviation 0.18795 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 16.38604 minutes | 0.59398 Percentage of Injected Dose | Standard Deviation 0.1154 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 32.41194 minutes | 2.13730 Percentage of Injected Dose | Standard Deviation 0.76985 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 53.21428 minutes | 4.89330 Percentage of Injected Dose | Standard Deviation 1.4169 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 78.27645 minutes | 9.38103 Percentage of Injected Dose | Standard Deviation 3.07024 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 97.78638 minutes | 12.93725 Percentage of Injected Dose | Standard Deviation 4.9134 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 144.06733 minutes | 20.76320 Percentage of Injected Dose | Standard Deviation 5.05449 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 187.27612 minutes | 25.22968 Percentage of Injected Dose | Standard Deviation 6.0905 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 213.49112 minutes | 29.06417 Percentage of Injected Dose | Standard Deviation 9.2925 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 258.12780 minutes | 34.50070 Percentage of Injected Dose | Standard Deviation 9.3855 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 304.21875 minutes | 36.95242 Percentage of Injected Dose | Standard Deviation 10.99721 |
| [18F]GTP1 | Total Source Organ Counts Based on Individualized Organ Volumes of Interest (VOIs) | Mean collect time: 337.49112 minutes | 39.75663 Percentage of Injected Dose | Standard Deviation 10.21783 |