NIH Clinical Research Studies

Protocol Number: 08-M-0158

Active Accrual, Protocols Recruiting New Patients

Title:
PET Imaging of Peripheral Benzodiazepine Receptors Using [11C](R)-PK 11195 and [11C]PBR28
Number:
08-M-0158
Summary:
This study will use positron emission tomography (PET) to measure a receptor in the brain that is involved in inflammation. It will test two radioactive chemicals used in the procedure to see if the newer chemical, [(11)C]B, is as good or better than the older one, [(11)C]A, for measuring brain inflammation.

Healthy volunteers 18 years of age and older may be eligible for this study. Participants undergo an evaluation, [(11)C]A PET scan, [(11)C]B PET scan and magnetic resonance imaging (MRI), as follows:

Evaluation

Medical history and physical examination, blood and urine tests

PET scans

-[(11)C]A scan. A catheter (plastic tube) is placed in an arm vein for injection of the [(11)C]A isotope. Some patients also have a catheter placed in an artery in the wrist to collect arterial blood samples during the scan. Subjects then lie on the scanner bed and a special mask is fitted to the head to help keep the subject's head still during the procedure. Following an 8-minute scan to calibrate the scanner, the [(11)C]A is injected into the catheter in the vein and pictures are taken that show where chemicals related to inflammation are present. The procedure takes about 2.5 hours.

-[(11)C]B scan. The procedure is the same as above for [(11)C]A, except the isotope used is [(11)C]B.

MRI scan.

This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies on a table that can slide in and out of the scanner (a metal cylinder), wearing earplugs to muffle loud noises that occur during the scan.

Sponsoring Institute:
National Institute of Mental Health (NIMH)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

-Subjects must be healthy and at least 18 years of age.

EXCLUSION CRITERIA:

-Current psychiatric disease, substance abuse or severe systemic disease based on history and physical exam.

-Laboratory tests with clinically significant abnormalities.

-Prior participation in other research protocols or clinical care in the last year such that radiation exposure, including that from this protocol, would exceed the guidelines set by the Radiation Safety Committee (RSC).

-Pregnancy or breast feeding.

-Positive result on urine screen for illicit drugs.

-Subjects who cannot lie on their back for extended periods of time.

-Subjects with significant claustrophobia who cannot tolerate an MRI scan.

-Subjects with cardiac pacemakers or metal in their bodies.

Special Instructions:
Currently Not Provided
Keywords:
Neuroinflammation
PBR28
PET Imaging
Recruitment Keyword(s):
Health Volunteer
HV
Condition(s):
Healthy
Investigational Drug(s):
[11C](R)-PK 11195
[11C]PBR 28
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Mental Health

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Anholt RR, De Souza EB, Oster-Granite ML, Snyder SH. Peripheral-type benzodiazepine receptors: autoradiographic localization in whole-body sections of neonatal rats. J Pharmacol Exp Ther. 1985 May;233(2):517-26.

Banati RB, Myers R, Kreutzberg GW. PK ('peripheral benzodiazepine')--binding sites in the CNS indicate early and discrete brain lesions: microautoradiographic detection of [3H PK11195 binding to activated microglia. J Neurocytol. 1997 Feb;26(2):77-82.

Banati RB, Newcombe J, Gunn RN, Cagnin A, Turkheimer F, Heppner F, Price G, Wegner F, Giovannoni G, Miller DH, Perkin GD, Smith T, Hewson AK, Bydder G, Kreutzberg GW, Jones T, Cuzner ML, Myers R. The peripheral benzodiazepine binding site in the brain in multiple sclerosis: quantitative in vivo imaging of microglia as a measure of disease activity. Brain. 2000 Nov;123 ( Pt 11):2321-37.

Active Accrual, Protocols Recruiting New Patients

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