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

NCT00250172 | Completed Phase 1

• 2 other identifiers: 06000206-M-0002
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 imaging (MRI). ...

Conditions

Dosimetry; Healthy

Keywords

Dosimetry; Pharmacokinetics; Compartment Analysis; Reproducibility; Healthy Volunteer; HV

Interventions

[C-11](R)-rolipram DRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

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)

• 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.

  PMID: 7830108 BACKGROUND

• 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. doi: 10.1097/00004032-197308000-00009. No abstract available.

  PMID: 4784245 BACKGROUND

• 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. doi: 10.1210/edrv-16-3-370. No abstract available.

  PMID: 7671852 BACKGROUND

Study Officials

• Masahiro Fujita, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2005
• First Posted: November 7, 2005
• Study Start: October 31, 2005
• Primary Completion: February 5, 2009
• Study Completion: February 5, 2009
• Last Updated: December 16, 2019

Record last verified: 2014-09-15

Locations

US (1)