Translocator Protein and Inflammation After Traumatic Brain Injury
PET Imaging of Translocator Protein in Subjects With Traumatic Brain Injury
Sponsor study identifier
Secondary identifiers
interventional
52
1 country
1
Study Start
January 20, 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 28, 2017
Actual (reported)Study Completion
September 28, 2017
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 28, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 20, 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 6, 2012
Actual (reported)March 8, 2012
Actual (reported)September 28, 2017
Actual (reported)September 28, 2017
Actual (reported)July 30, 2021
Actual (reported)Receptor Binding (Vt)
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).
120 minutes from the start of the PET scan
Receptor Binding Corrected for Plasma (Vt/fp)
Total distribution volume divided by plasma free fraction (fp) of \[C-11\]PBR28. Measured with PET and arterial input function (concentration of radioligand in arterial plasma over time).
120 minutes from the start of the PET scan
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to baseline brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to repeat brain positron emission tomography (PET) scan in Acute (\< 5 months post-injury) traumatic brain injury (TBI) patients.
Brain PET with \[11C\]PBR28. 11C\]PBR28 is a new PET ligand that images TSPO with high levels of specific binding.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Brown AK, Fujita M, Fujimura Y, Liow JS, Stabin M, Ryu YH, Imaizumi M, Hong J, Pike VW, Innis RB. Radiation dosimetry and biodistribution in monkey and man of 11C-PBR28: a PET radioligand to image inflammation. J Nucl Med. 2007 Dec;48(12):2072-9. doi: 10.2967/jnumed.107.044842. Epub 2007 Nov 15.
Cernak I, O'Connor C, Vink R. Activation of cyclo-oxygenase-2 contributes to motor and cognitive dysfunction following diffuse traumatic brain injury in rats. Clin Exp Pharmacol Physiol. 2001 Nov;28(11):922-5. doi: 10.1046/j.1440-1681.2001.03549.x.
Robert Innis, MD, PhD
National Institute of Mental Health (NIMH)
52 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2012
First Posted
March 8, 2012
Study Start
January 20, 2012
Date type not reportedThis date has not been verified as actual or estimated.
Sensorimotor Rhythm Brain-Computer Interface Switch to Operate Assistive Technology
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to brain positron emission tomography (PET) scan in Chronic (5 months - 5 years post-injury) traumatic brain injury (TBI) patients.
Single intravenous injection of \[C-11\]PBR28, \~10-20 mCi, prior to brain positron emission tomography (PET) scan in Healthy Subjects.
Contact the study team to confirm eligibility.
Conzen M, Ebel H, Swart E, Skreczek W, Dette M, Oppel F. Long-term neuropsychological outcome after severe head injury with good recovery. Brain Inj. 1992 Jan-Feb;6(1):45-52. doi: 10.3109/02699059209008121.
Paul S, Gallagher E, Liow JS, Mabins S, Henry K, Zoghbi SS, Gunn RN, Kreisl WC, Richards EM, Zanotti-Fregonara P, Morse CL, Hong J, Kowalski A, Pike VW, Innis RB, Fujita M. Building a database for brain 18 kDa translocator protein imaged using [11C]PBR28 in healthy subjects. J Cereb Blood Flow Metab. 2019 Jun;39(6):1138-1147. doi: 10.1177/0271678X18771250. Epub 2018 May 11.
Primary Completion
September 28, 2017
Actual (reported)Study Completion
September 28, 2017
Actual (reported)Last Updated
July 30, 2021
Results First Posted
July 30, 2021
Record last verified: 2017-09-28
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Source: ClinicalTrials.gov.
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