Trial Outcomes & Findings for [18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects (NCT NCT05564429)
NCT ID: NCT05564429
Last Updated: 2024-07-09
Results Overview
Participant received whole body PET scan and Uptake of \[18F\]SF12051 was measured using the Siemens Biograph mCT. Organ dosimetry was measured as microsieverts per mega-becquerel (uSv/MBq).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Up to 120 minutes during the scan
Results posted on
2024-07-09
Participant Flow
Participant milestones
| Measure |
High Affinity Binder (HAB) Translocator Protein (TSPO) Genotype
Healthy participants with HAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 \& 3 had whole body PET scan and phase 2 had brain PET scan.
|
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 \& 3 had whole body PET scan and phase 2 had brain PET scan.
|
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 \& 3 had whole body PET scan and phase 2 had brain PET scan.
|
|---|---|---|---|
|
Phase 1
STARTED
|
0
|
0
|
1
|
|
Phase 1
Whole Body PET Scan
|
0
|
0
|
1
|
|
Phase 1
COMPLETED
|
0
|
0
|
1
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
3
|
2
|
3
|
|
Phase 2
Brain PET Scan
|
3
|
2
|
3
|
|
Phase 2
COMPLETED
|
3
|
2
|
3
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Phase 3
STARTED
|
1
|
0
|
0
|
|
Phase 3
Whole Body PET Scan
|
1
|
0
|
0
|
|
Phase 3
COMPLETED
|
1
|
0
|
0
|
|
Phase 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
[18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects
Baseline characteristics by cohort
| Measure |
High Affinity Binder (HAB) Translocator Protein (TSPO) Genotype
n=4 Participants
Healthy participants with HAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan.
|
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
n=2 Participants
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan.
|
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
n=4 Participants
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutes during the scanPopulation: Participant who completed phase 1 of the study. Whole body PET imaging was done for one subject with a low injection activity of \~2 mCi to confirm that no organ has prominently high uptake of \[18F\]SF12051.
Participant received whole body PET scan and Uptake of \[18F\]SF12051 was measured using the Siemens Biograph mCT. Organ dosimetry was measured as microsieverts per mega-becquerel (uSv/MBq).
Outcome measures
| Measure |
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
n=1 Participants
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body PET scan.
|
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
|---|---|---|---|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Brain
|
6 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Heart
|
17 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Liver
|
8 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Kidneys
|
16 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Lungs
|
11 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Stomach
|
18 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Spleen
|
15 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Bone Marrow
|
15 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Gallbladder
|
16 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Small intestine
|
25 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Testicles
|
14 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Urinary bladder
|
21 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 1
Whole body
|
15 uSv/MBq
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 120 minutes during the scanPopulation: All participants who completed phase 2 of the study. Data for one participant was not useable.
Participant received brain PET scan and Uptake of \[18F\]SF12051 was measured using the Siemens Biograph mCT. Volume of distribution (Vt) was calculated via 2-Tissue-Compartment Model with plasma input function.
Outcome measures
| Measure |
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
n=3 Participants
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body PET scan.
|
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
n=2 Participants
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
n=2 Participants
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
|---|---|---|---|
|
Brain PET Uptake of [18F]SF12051 - Phase 2
|
0.833333333 mL*cm-3
Standard Deviation 0.328
|
0.40 mL*cm-3
Standard Deviation 0.0225
|
0.90 mL*cm-3
Standard Deviation 0.036
|
PRIMARY outcome
Timeframe: Up to 120 minutes during the scanPopulation: Participant who completed phase 3 of the study.
Participant received whole body PET scan and Uptake of \[18F\]SF12051 was measured using the Siemens Biograph mCT. Organ dosimetry was measured as microsieverts per mega-becquerel (uSv/MBq).
Outcome measures
| Measure |
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
n=1 Participants
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body PET scan.
|
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
|---|---|---|---|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Heart
|
15 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Liver
|
12 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Kidneys
|
17 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Brain
|
5 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Lungs
|
13 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Stomach
|
15 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Spleen
|
10 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Bone Marrow
|
12 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Gallbladder
|
20 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Small intestine
|
20 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Ovaries
|
15 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Urinary bladder
|
12 uSv/MBq
|
—
|
—
|
|
Whole Body PET Uptake of [18F]SF12051 - Phase 3
Whole body
|
15 uSv/MBq
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 120 minutes during the scanPopulation: Participant who completed phase 1 of the study.
Biodistribution and dosimetry of \[18F\]SF12051 in healthy subjects was measured as area under the curve from 0-120 minutes shown as concentration of radioactivity reported as standard uptake values (SUV) x time during the course of the scans for each organ.
Outcome measures
| Measure |
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
n=1 Participants
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body PET scan.
|
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
|---|---|---|---|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Kidneys
|
345.5662222 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Lungs
|
93.28630134 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Stomach
|
348.3474892 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Spleen
|
438.5340085 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Urinary bladder
|
271.9311702 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Bone Marrow
|
868.883177 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Gallbladder
|
152.5233703 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Small intestine
|
218.0137982 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Testicles
|
71.86889245 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Brain
|
84.78437744 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Heart
|
497.9329916 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 1
Liver
|
357.8754055 SUV*minutes
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 120 minutes during the scanPopulation: Participant who completed phase 3 of the study
Biodistribution and dosimetry of \[18F\]SF12051 in healthy subjects was measured as area under the curve from 0-120 minutes shown as concentration of radioactivity reported as standard uptake values (SUV) x time during the course of the scans for each organ.
Outcome measures
| Measure |
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
n=1 Participants
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body PET scan.
|
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by brain positron emission tomography (PET) scan.
|
|---|---|---|---|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Heart
|
491.710075 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Liver
|
141.3314325 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Kidneys
|
215.9146934 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Gallbladder
|
115.1009919 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Small intestine
|
144.9270488 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Ovaries
|
67.67155656 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Brain
|
56.6832231 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Lungs
|
92.14993947 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Stomach
|
170.0881894 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Spleen
|
238.9553087 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Urinary bladder
|
234.1664917 SUV*minutes
|
—
|
—
|
|
Area Under the Organ Time-Activity Curves From 0-120 - Phase 3
Bone Marrow
|
230.539214 SUV*minutes
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 120 minutes during the scanPopulation: Data were not collected due to termination of the study
Assess test-retest variability of \[18F\]SF12051 using absolute test-retest variability (aTRV). aTRV = \| retest value - test value\| / (test value + retest value) \* 200%
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 120 minutes during the scanPopulation: Data were not collected due to termination of the study
Assess test-retest reliability of \[18F\]SF12051 using intraclass correlation coefficient (ICC) ICC = (between-subject standard deviation)\^2/\[(between-subject standard deviation)\^2 + (within-subject standard deviation)\^2\]
Outcome measures
Outcome data not reported
Adverse Events
High Affinity Binder (HAB) Translocator Protein (TSPO) Genotype
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Affinity Binder (HAB) Translocator Protein (TSPO) Genotype
n=4 participants at risk
Healthy participants with HAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan.
|
Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype
n=2 participants at risk
Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan.
|
Mixed Affinity Binder (MAB) Translocator Protein (TSPO) Genotype
n=4 participants at risk
Healthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan.
|
|---|---|---|---|
|
Gastrointestinal disorders
Pain
|
25.0%
1/4 • Up to five day post PET scan visit
|
0.00%
0/2 • Up to five day post PET scan visit
|
0.00%
0/4 • Up to five day post PET scan visit
|
Additional Information
Dr Robert Innis
National Institute of Mental Health (NIMH)
Phone: 301-594-1368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place