Overview

PET Whole Body Biodistribution and Test Retest Bain Imaging Studies Using a Phosphodiesterase 4 Inhibitor (R)-[11C]Rolipram

Status:
Completed
Trial end date:
2009-02-05
Target enrollment:
0
Participant gender:
All
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 imaging (MRI). ...
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Mental Health (NIMH)
Treatments:
Phosphodiesterase 4 Inhibitors
Rolipram
Criteria
- INCLUSION CRITERIA:

All subjects must be healthy and aged 18 65 years.

EXCLUSION CRITERIA:

PART 1 (WHOLE BODY IMAGING STUDIES):

1. Current psychiatric disease, substance abuse or severe systemic disease based on
history and physical exam, poor vision or hearing.

2. Laboratory tests with clinically significant abnormalities.

3. 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.

4. Pregnancy and breast feeding.

5. Positive HIV test.

6. Positive urine drug screen.

PART 2 (TEST RETEST BRAIN IMAGING STUDIES):

1. Current psychiatric disease, substance abuse or severe systemic disease based on
history and physical exam, poor vision or hearing.

2. Laboratory tests with clinically significant abnormalities.

3. 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.

4. Pregnancy and breast feeding.

5. Claustrophobia.

6. Presence of ferromagnetic metal in the body or heart pacemaker.

7. Positive HIV test.

8. A history of brain disease.