Translocator Protein and Inflammation After Traumatic Brain Injury
- 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.
- To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic brain injury.
- 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.
- 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 Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||PET Imaging of Translocator Protein in Subjects With Traumatic Brain Injury|
- Binding of [(11)C]PBR28.
- Neurocognitive assessment scores and clinical evaluations
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547780
|Contact: Holly Giesen||(301) firstname.lastname@example.org|
|Contact: Masahiro Fujita, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Masahiro Fujita, M.D.||National Institute of Mental Health (NIMH)|