PET Imaging of Peripheral Benzodiazepine Receptors

NCT00696371 | Completed

• 2 other identifiers: 08015808-M-0158
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. ...

Conditions

Healthy

Keywords

Neuroinflammation; PBR28; PET Imaging; Health Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• The first goal of this study is to compare [11C]PBR28 and [11C](R)-PK 11195 as radioligands in the measurement of PBR in healthy human subjects. Our primary outcome measures will be the distribution volume and time stability of each radioligand.

Secondary Outcomes (1)

• The second goal is to identify non-binders, that is, subjects that do not demonstrate any binding to [11C]PBR28.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 2987488 BACKGROUND

• 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. doi: 10.1023/a:1018567510105.

  PMID: 9181482 BACKGROUND

• 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. doi: 10.1093/brain/123.11.2321.

  PMID: 11050032 BACKGROUND

MeSH Terms

Conditions

Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William C Kreisl, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 12, 2008
• Study Start: June 6, 2008
• Study Completion: August 19, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-08-19

Locations

US (1)