Status:
COMPLETED
PET Whole Body Biodistribution and Test Retest Bain Imaging Studies Using a Phosphodiesterase 4 Inhibitor (R)-[11C]Rolipram
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Dosimetry
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to measure a particular protein in the brain called the phosphodiesterase by using the imaging techniques of positron emission tomography (PET) and magnetic resonance imag...
Detailed Description
Both basic and clinical studies have indicated that the 3', 5'-cyclic adenosine monophosphate (cAMP) system plays critical roles in several brain diseases, particularly in mood disorders and drug addi...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All subjects must be healthy and aged 18 65 years.
- EXCLUSION CRITERIA:
- PART 1 (WHOLE BODY IMAGING STUDIES):
- Current psychiatric disease, substance abuse or severe systemic disease based on history and physical exam, poor vision or hearing.
- 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 a half of the annual limits. Because human dosimetry of (R)-\[(11)C\]rolipram has been estimated using rhesus monkeys, the total exposure including that from the (R)-\[(11)C\]rolipram whole body imaging study will be limited to a half of the RSC guidelines.
- Pregnancy and breast feeding.
- Positive HIV test.
- Positive urine drug screen.
- PART 2 (TEST RETEST BRAIN IMAGING STUDIES):
- Current psychiatric disease, substance abuse or severe systemic disease based on history and physical exam, poor vision or hearing.
- Laboratory tests with clinically significant abnormalities.
- Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits. Results of part 1 will be used to calculate total radiation exposure within a year.
- Pregnancy and breast feeding.
- 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 :
October 31 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00250172
Start Date
October 31 2005
End Date
February 5 2009
Last Update
December 16 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892