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PET Whole Body Imaging Using a Peripheral Benzodiazepine Receptor Ligand [C-11]PBR28

This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00407693
  Purpose

In this study we will examine where the radioactive tracer [11C]PBR28 is distributed in the body of healthy volunteers to calculate the radiation exposure to organs of the body. We will also test if [11C]PBR28 binds to your blood cells and compare with the binding in PET images.


Condition Intervention
Healthy
Drug: [11C]PRB28

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:   PET Whole Body Imaging Using a Peripheral Benzodiazepine Receptor Ligand [C-11]PBR28

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Biodistribution of [C-11]PBR28

Estimated Enrollment:   40
Study Start Date:   November 2006

Intervention Details:
    Drug: [11C]PRB28
    N/A
Detailed Description:

The peripheral benzodiazepine receptor (PBR) is distinct from central benzodiazepine receptors associated with GABAA receptors. Although PBR was initially identified in peripheral organs such as kidneys, endocrine glands and lungs, later studies identified PBR in the central nervous system. In normal conditions, PBR is expressed in low levels in some neurons and glial cells. PBR can be a clinically useful marker to detect neuroinflammation because activated microglial cells in inflammatory areas express much greater levels of PBR than in microglial cells in resting conditions.

PBR has been imaged with positron emission tomography (PET) using [11C]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline carboxamide (PK11195). However, this classical ligand provides only low levels of specific signals and is not sensitive to detect changes that occurred in vivo. Recently we developed a new ligand, N-acetyl-N-(2-[11C]methoxybenzyl)-2-phenoxy-5-pyridinamine ([11C]PBR28), which showed much greater specific signals than [11C]PK11195 in non-human primates. Therefore, [11C]PBR28 is a promising PET ligand. However, radiation absorbed doses have not been estimated from human whole body imaging.

The purpose of this protocol is to estimate radiation absorbed doses of [11C]PBR28 by performing whole body imaging studies on healthy human subjects. The results of this overall study are required to apply this PET ligand in various neurological and psychiatric disorders in the future.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria
  • INCLUSION CRITERIA:

All subjects must be healthy and aged 18-65 years.

EXCLUSION CRITERIA:

The exclusion criteria are shown below:

  • 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 and breast feeding.
  • Positive HIV test.
  • Cannot lie flat for 2 - 3 h.
  • Taking benzodiazepines.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407693

Contacts
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010    

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike     Recruiting
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information


NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   070035, 07-M-0035
First Received:   December 2, 2006
Last Updated:   September 19, 2008
ClinicalTrials.gov Identifier:   NCT00407693
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Dosimetry  
Effective Dose  
Radiation-Absorbed Dose  

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on October 10, 2008




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