Protocol Number: 06-M-0002

Title:

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

Number:

06-M-0002

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).

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:

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.

9. Positive urine drug screen.

Special Instructions:

Currently Not Provided

Keywords:

Dosimetry

Pharmacokinetics

Compartment Analysis

Reproducibility

Recruitment Keyword(s):

Healthy Volunteer

HV

Condition(s):

Dosimetry

Healthy

Investigational Drug(s):

[C-11](R)-rolipram

Investigational Device(s):

None

Intervention(s):

Drug: [C-11](R)-rolipram

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):

Abi-Dargham A, Gandelman M, Zoghbi SS, Laruelle M, Baldwin RM, Randall P, Zea-Ponce Y, Charney DS, Hoffer PB, Innis RB. Reproducibility of SPECT measurement of benzodiazepine receptors in human brain with iodine-123-iomazenil. J Nucl Med. 1995 Feb;36(2):167-75.

Cloutier RJ, Smith SA, Watson EE, Snyder WS, Warner GG. Dose to the fetus from radionuclides in the bladder. Health Phys. 1973 Aug;25(2):147-61. No abstract available.

Conti M, Nemoz G, Sette C, Vicini E. Recent progress in understanding the hormonal regulation of phosphodiesterases. Endocr Rev. 1995 Jun;16(3):370-89. Review. No abstract available.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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