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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 is a Phase 1 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 52 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01547780
The ClinicalTrials.gov registry entry for NCT01547780 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [11C]PBR28 and Positron Emission Tomography (PET) is the first listed.
NCT01547780 reports 0 study locations.
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.
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