CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
[11C]PBR28 and Positron Emission Tomography (PET)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01547780
NCT01547780Phase 2Completed

PET Imaging of Translocator Protein in Subjects With Traumatic Brain Injury

National Institute of Mental Health (NIMH)·interventional·Posted Mar 8, 2012·Updated Jul 30, 2021

In Brief

A Phase 2 clinical trial evaluating [11C]PBR28 and Positron Emission Tomography (PET) for Traumatic Brain Injury (TBI) and Healthy. Completed, enrolled 52 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2012
Enrollment StartJan 20, 2012
Primary CompletionSep 28, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 14.3 years ago

Interventions

[11C]PBR28 and Positron Emission Tomography (PET)drug

Brain PET with \[11C\]PBR28. 11C\]PBR28 is a new PET ligand that images TSPO with high levels of specific binding.