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NCT01547780 · ClinicalTrials.gov registry record · Phase 1
Translocator Protein and Inflammation After Traumatic Brain Injury
A Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01547780: Completed Phase 1 study, sponsored by National Institute of Mental Health (NIMH).
NCT01547780 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01547780, a Phase 1 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
Background: \- People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as \[11C\]PBR28 can be used to study TSPO and inflammation in the brain of people with TBI. Objectives: \- To test whether \[11C\]PBR28 can be used to study changes in the brain after a traumatic brain injury. Eligibility: * Individuals at least 18 years of age who have had TBI and have had a brain scan that shows signs of inflammation. * Healthy volunteers at least 18 years of age. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * All participants will have two brain scans during an outpatient visit. A magnetic resonance imaging scan will study brain activity. A positron emission tomography (PET) scan will use \[11C\]PBR28 to look for signs of TSPO and brain inflammation. * Participants with TBI will have two PET scans within 10 days of the head injury, and a PET scan around 90 days after the injury. They may also have MRI scans under this or another study. Tests of thinking, memory, and concentration will be used to study the effects of the injury and inflammation
Primary Outcome
To determine total distribution volume of \[C-11\]PBR28 in the whole brain using PET and arterial input function (concentration of radioligand in arterial plasma over time).
Interventions
- DRUG [11C]PBR28 and Positron Emission Tomography (PET)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-01-20 |
| Est. Completion | 2017-09-28 |
| Phase | Phase 1 |
What the finished NCT01547780 record still lists
NCT01547780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which [11C]PBR28 and Positron Emission Tomography (PET) is the first listed.
NCT01547780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01547780 about?
NCT01547780 is a clinical study titled "Translocator Protein and Inflammation After Traumatic Brain Injury". Background: \- People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as \[11C\]PBR28 can be used to study TSPO and inflammation in th...
What is the current status of trial NCT01547780?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2012-01-20. Estimated completion is 2017-09-28.
What interventions are being tested in trial NCT01547780?
The interventions under investigation include: [11C]PBR28 and Positron Emission Tomography (PET) (DRUG).
Who is sponsoring clinical trial NCT01547780?
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 NCT01547780's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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