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Translocator Protein and Inflammation After Traumatic Brain Injury

NCT01547780 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2021-07-30

Study results available
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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

Conditions

  • Traumatic Brain Injury (TBI)
  • Healthy

Interventions

DRUG

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

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

Sponsors & Collaborators

  • Suburban Hospital

    collaborator OTHER

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Robert Innis, MD, PhD · National Institute of Mental Health (NIMH)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-20
Primary Completion
2017-09-28
Completion
2017-09-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01547780 on ClinicalTrials.gov