Status:
COMPLETED
Brain Peripheral Benzodiazepine Receptors in Patients With Multiple Sclerosis
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study will use positron emission tomography (PET) to measure a brain protein called peripheral benzodiazepine receptor (PBR) in patients with multiple sclerosis. PBR is created during the inflamm...
Detailed Description
OBJECTIVE: The primary objective of this study is to measure brain peripheral benzodiazepine receptor (PBR) expression as a marker of neuroinflammation in subjects with MS using \[(11)C\]PBR28 PET im...
Eligibility Criteria
Inclusion
- SUBJECTS WITH MULTIPLE SCLEROSIS - INCLUSION CRITERIA:
- Ages between 18 and 70, inclusive.
- Diagnosis of definite MS according to published criteria.
- The presence of at least one gadolinium-enhancing lesion on the screening brain magnetic resonance image (MRI), and T2 lesion load volume greater than 5 cc.
- Subjects must be able to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.
- SUBJECTS WITH MULTIPLE SCLEROSIS - EXCLUSION CRITERIA:
- Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual guidelines.
- Homozyous for the low- affinity binding form of TSPO by TSPO genotype analysis ( Ala147Thr polymorphism in rs6971 SNP in exon 4 of the TSPO gene).
- Pregnancy and breast-feeding.
- Presence of ferromagnetic metal in the body or heart pacemaker.
- ECG with clinically significant abnormalities.
- Positive HIV test.
- Positive pregnancy test.
- Concurrent medical conditions including hepatic cirrhosis, end-stage renal disease or any acute and severe decompensation of disease that in the opinion of the investigator would compromise the safety of the patient.
- Subjects with cognitive impairment who are unable to provide written, informed consent.
- Subjects who have received immunomodulatory/disease-modifying therapy, including investigational MS therapy, within 12 weeks prior to PET imaging or who have received corticosteroids within 6 weeks prior to PET imaging.
- HEALTHY VOLUNTEERS - INCLUSION CRITERIA:
- All subjects must be healthy and aged 18-70 years.
- HEALTHY VOLUNTEERS - EXCLUSION CRITERIA:
- Homozyous for the low- affinity binding form of TSPO by TSPO genotype analysis ( Ala147Thr polymorphism in rs6971 SNP in exon 4 of the TSPO gene).
- Current psychiatric illness, substance abuse or severe systemic disease based on history and physical exam.
- ECG with clinically significant abnormalities. Any existing physical exam and ECG within one year will be reviewed and if none already exists in the chart, these will be obtained and reviewed.
- Laboratory tests with clinically significant abnormalities.
- Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual guidelines.
- Pregnancy and breast-feeding.
- Positive pregnancy test.
- Claustrophobia.
- Presence of ferromagnetic metal in the body or heart pacemaker.
- Positive HIV test.
- A history of brain disease.
Exclusion
Key Trial Info
Start Date :
February 5 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00432900
Start Date
February 5 2007
End Date
May 29 2013
Last Update
December 12 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892