PET Imaging of Brain 5-HT(1A) Receptors Using [(11)C](-)-RWAY

NCT00263523 | Completed Phase 1

• 2 other identifiers: 06004206-M-0042
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use positron emission tomography (PET) and magnetic resonance imaging (MRI) to measure a serotonin receptor subtype in the brain called 5-HT(1A). This receptor is a target for drug therapy to treat anxiety and depression. The study will see if a newly developed radioligand (radioactive substance used in PET scanning to study the receptor systems of the brain) called \[(11)C\](-)-RWAY is more effective than other radioligands currently used in brain receptor research. Healthy subjects 18-40 years of age may be eligible for this study. Candidates are screened with a physical examination, electrocardiogram, and blood and urine tests. Participants undergo PET and MRI scanning as follows: PET scan PET uses small amounts of a radioactive chemical called a tracer (in this case, \[(11)C\](-)-RWAY) that "labels" active areas of the brain. For the procedure, the subject lies on the scanner bed. A special mask is fitted to the subject's head and attached to the bed to help keep the head still during the scan so the images will be clear. A brief scan is done just before the tracer is injected to provide measures of the brain that will help in the precise calculation of information from subsequent scans. Then, the tracer is injected through a catheter (plastic tube) placed in the arm and pictures are taken for about 2 hours, while the subject lies still on the scanner bed. Subjects return to the clinic for blood and urine tests 24 hours after the scan. MRI The MRI scan is done within 1 year of the PET scan. MRI uses a magnetic field and radio waves to produce images of body tissues and organs-in this case, the brain. The subject lies on a table that is moved into the scanner (a tube-like device), wearing earplugs to muffle the noise of the machine during the scanning process. The space in the scanner is confining and may cause some people to be somewhat anxious. An intercom system allows the subject to speak with the staff member performing the study at all times during the procedure, and the procedure can be stopped at any time.

Conditions

Healthy Volunteers

Keywords

Serotonin; Positron Emission Tomograhy; Brain; Neurochemistry; Neurotransmitter; Healthy Volunteer; HV

Interventions

[11C] (-)-RWAY 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:

• Current psychiatric illness, substance abuse or severe systemic disease based on history and physical exam.
• Any existing physical exam and ECG within one year will be reviewed and if none already exists in the chart, these will be obtained and reviewed.
• 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.
• Pregnancy and breast feeding.
• Claustrophobia.
• Presence of ferromagnetic metal in the body or heart pacemaker.
• Positive HIV test.
• A history of brain disease.

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 (1)

• Burger C, Buck A. Requirements and implementation of a flexible kinetic modeling tool. J Nucl Med. 1997 Nov;38(11):1818-23.

  PMID: 9374364 BACKGROUND

MeSH Terms

Interventions

2, 3, 4, 5, 6, 7-hexahydro-1(4-(1(4-(2-methoxyphenyl)-piperazinyl))-2-phenylbutyry)-1H-azepine

Study Design

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

Study Record Dates

• First Submitted: December 8, 2005
• First Posted: December 8, 2005
• Study Start: December 5, 2005
• Study Completion: August 15, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-08-15

Locations

US (1)