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| ID | Type | Description | Link |
|---|---|---|---|
| 000674-M |
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due to futility
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Background:
Inflammation in the brain plays a role in many diseases. Being able to measure inflammation in a person's brain might help to diagnose and treat these diseases. One protein (TSPO) appears in higher numbers when inflammation affects the brain. To see TSPO when a person's body is scanned, researchers need a substance called a radiotracer that will attach to this protein and no other molecules.
Objective:
This study will test whether a new radiotracer ([18F]SF12051) can make TSPO appear on PET scans of a person's brain and body.
Eligibility:
Healthy people aged 18 and older.
Design:
This study requires 2 to 4 visits to the clinic.
All participants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function.
Some participants will have a positron emission tomography (PET) scan of the whole body. The radiotracer will be injected through a tube (catheter) placed in a vein in the arm. The PET scanner is a machine shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. The scan will take about 2 hours.
Some participants will have a PET scan of just their head. After they are injected with the radiotracer, they will lie on a bed with their head in the scanner. Blood will be drawn from a catheter in the wrist during the scan.
Some participants will have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a narrow bed that slides into a tube.
Study Description:
This study is intended to provide information on the novel [18F]SF12051 radioligand and its ability to localize and measure TSPO in the brain and body of healthy individuals.
Objectives:
Primary Objective: To study the brain uptake of [18F]SF12051 and perform kinetic modeling of the [18F]SF12051 in the three different TSPO genotypes.
Secondary Objectives: To study the brain retest characteristics, biodistribution and dosimetry of [18F]SF12051 in healthy subjects.
Endpoints:
Primary Endpoint: The distribution volume of the radioligand and stability over time calculated with compartmental modeling, attention paid to differences in mean distribution volumes between TSPO genotypes for determining genotype sensitivity.
Secondary Endpoints: Retest variability and reliability and organ time- activity curves to determine biodistribution and dosimetry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High affinity binder (HAB) Translocator Protein (TSPO) genotype | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-SF12051 | Drug | Injected intravenously followed by PET scanning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole Body PET Uptake of [18F]SF12051 - Phase 1 | 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). | Up to 120 minutes during the scan |
| Brain PET Uptake of [18F]SF12051 - Phase 2 | 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. | Up to 120 minutes during the scan |
| Whole Body PET Uptake of [18F]SF12051 - Phase 3 | 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). | Up to 120 minutes during the scan |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Organ Time-Activity Curves From 0-120 - Phase 1 | 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. | Up to 120 minutes during the scan |
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To be eligible to participate in this study, an individual must meet all of the following criteria:
Aged 18 years or older.
Healthy based on medical history, physical examination, and laboratory testing.
Able to provide informed consent.
Willing and able to complete all study procedures.
Have been screened for TSPO genotype under 01-M-0254 "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants".
Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists*.
Agree to adhere to the lifestyle considerations
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Clinically significant abnormalities on EKG or laboratory testing. This includes CBC; acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen); hepatic panel (alkaline phosphatase, ALT, AST, bilirubin total, and bilirubin direct); mineral panel (albumin, calcium, magnesium, phosphorus); prothrombin and partial prothrombin tests.
Participants should not have taken NSAIDs or willow bark tea for two weeks prior to the PET scan.
Any current Axis I diagnosis.
Positive test for HIV.
Unable to have an MRI scan*.
History of neurologic illness or injury with the potential to affect study data interpretation.
History of seizures, other than in childhood and related to fever.
Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
Pregnancy or breast feeding.
Able to get pregnant but does not use birth control.
Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use affects the function of daily life.
Unable to travel to NIH.
National Institute of Mental Health (NIMH) staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.
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| Name | Affiliation | Role |
|---|---|---|
| Robert B Innis, M.D. | National Institute of Mental Health (NIMH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39654356 | Derived | Yan X, Simeon FG, Liow JS, Morse CL, Jana S, Montero Santamaria JA, Jenkins M, Zoghbi SS, Pike VW, Innis RB, Zanotti-Fregonara P. [18F]SF51, a novel 18F-labeled PET radioligand for translocator protein 18kDa (TSPO) in brain, works well in monkeys but fails in humans. J Cereb Blood Flow Metab. 2025 Feb;45(2):365-372. doi: 10.1177/0271678X241304924. Epub 2024 Dec 9. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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.The results will be submitted to ClinicalTrials.gov
18 months after closure of protocol
BTRIS
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
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| Phase 2 |
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| Phase 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Low Affinity Binder (LAB) Translocator Protein (TSPO) Genotype |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Whole Body PET Uptake of [18F]SF12051 - Phase 1 | 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). | 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. | Posted | Number | uSv/MBq | Up to 120 minutes during the scan |
|
Up to five day post PET scan visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Robert Innis | National Institute of Mental Health (NIMH) | 301-594-1368 | robert.innis@nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 5, 2023 | Apr 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Area Under the Organ Time-Activity Curves From 0-120 - Phase 3 | 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. | Up to 120 minutes during the scan |
| Test-Retest Variability of [18F]SF12051 | Assess test-retest variability of [18F]SF12051 using absolute test-retest variability (aTRV). aTRV = | retest value - test value| / (test value + retest value) * 200% | Up to 120 minutes during the scan |
| Test-Retest Reliability of [18F]SF12051 | 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] | Up to 120 minutes during the scan |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Healthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Primary | Brain PET Uptake of [18F]SF12051 - Phase 2 | 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. | All participants who completed phase 2 of the study. Data for one participant was not useable. | Posted | Mean | Standard Deviation | mL*cm-3 | Up to 120 minutes during the scan |
|
|
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| Primary | Whole Body PET Uptake of [18F]SF12051 - Phase 3 | 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). | Participant who completed phase 3 of the study. | Posted | Number | uSv/MBq | Up to 120 minutes during the scan |
|
|
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| Secondary | Area Under the Organ Time-Activity Curves From 0-120 - Phase 1 | 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. | Participant who completed phase 1 of the study. | Posted | Number | SUV*minutes | Up to 120 minutes during the scan |
|
|
|
| Secondary | Area Under the Organ Time-Activity Curves From 0-120 - Phase 3 | 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. | Participant who completed phase 3 of the study | Posted | Number | SUV*minutes | Up to 120 minutes during the scan |
|
|
|
| Secondary | Test-Retest Variability of [18F]SF12051 | Assess test-retest variability of [18F]SF12051 using absolute test-retest variability (aTRV). aTRV = | retest value - test value| / (test value + retest value) * 200% | Data were not collected due to termination of the study | Posted | Up to 120 minutes during the scan |
|
|
| Secondary | Test-Retest Reliability of [18F]SF12051 | 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] | Data were not collected due to termination of the study | Posted | Up to 120 minutes during the scan |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| Title | Measurements |
|---|
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| Kidneys |
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| Lungs |
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| Stomach |
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| Spleen |
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| Bone Marrow |
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| Gallbladder |
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| Small intestine |
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| Ovaries |
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| Urinary bladder |
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| Whole body |
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| Title | Measurements |
|---|---|
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| Kidneys |
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| Lungs |
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| Stomach |
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| Spleen |
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| Urinary bladder |
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| Bone Marrow |
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| Gallbladder |
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| Small intestine |
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| Testicles |
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| Title | Measurements |
|---|---|
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| Kidneys |
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| Lungs |
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| Stomach |
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| Spleen |
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| Urinary bladder |
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| Bone Marrow |
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| Gallbladder |
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| Small intestine |
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| Ovaries |
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