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NCT05564429 · ClinicalTrials.gov registry record · Phase 1
[18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT05564429: Clinical Trial Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT05564429 is a Phase 1 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05564429, a Phase 1 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- DRUG 18F-SF12051
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-02-02 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 1 |
Why NCT05564429 stopped before completion
NCT05564429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which 18F-SF12051 is the first listed.
NCT05564429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05564429 about?
NCT05564429 is a clinical study titled "[18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects". 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,...
What is the current status of trial NCT05564429?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-02-02. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT05564429?
The interventions under investigation include: 18F-SF12051 (DRUG).
Who is sponsoring clinical trial NCT05564429?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05564429's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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