Positron Emission Tomography Imaging of Dopamine Receptors Using the Tracer [11C]NNC-112

March 3, 2008 updated by: National Institute of Mental Health (NIMH)

Whole Body Study of [11C]NNC-112 PET Imaging of Dopamine D1 Receptors

This study will investigate the use of [11C]NNC-112 in positron emission tomography (PET) scanning. PET is a technique that uses radioactive isotopes called tracers to provide images of the brain. Injected into the body, the isotopes lose their "radioactive strength" over time, sending out rays that can be picked up and "seen" by special detectors connected to a computer. The computer then makes a picture of the brain. This study will examine the distribution in the body of a new tracer called [11C]NNC-112.

Healthy normal volunteers between 18 and 70 years of age may be eligible for this study. Candidates are screened with a physical examination and blood and urine tests, including a urine drug screen. Women up to age 55 also have a pregnancy test.

Participants have a PET scan using the [11C]NNC-112 tracer. For this procedure, a catheter (small plastic tube) is placed into a vein in the subject's arm for injecting the tracer. Then, the subject lies on the scanner bed. After a preliminary "transmission scan," the tracer is injected, and PET scans are taken from the head to the upper thigh over a period of about 2 hours to show the distribution of radioactivity in the body. Blood pressure, breathing rate, and heart rate are checked before and after injection of the tracer, and blood and urine samples are collected after the PET scan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Abnormalities in dopaminergic neurotransmission have been implicated in several neurodegenerative and psychiatric disorders, such as Parkinson's disease, schizophrenia, attention-deficit-hyperactivity disorder and drug dependence. Among the Dopamine (DA) receptors, D1 receptors are understood to be involved in the regulation of motor and cognitive activity by modulating DAergic function. Neuroreceptor imaging with Positron Emission Tomography (PET) and Single Photon Emission Computerized Tomography (SPECT) allows in vivo quantification of the density and distribution of D1 receptors in humans. Recently, a new and superior PET radioligand for in vivo quantification of D1 receptors in extrastriatal regions has been developed. [11C]NNC-112 is a D1 radiotracer with high specific to nonspecific binding, making it suitable for imaging low density D1 receptors in extrastriatal regions such as the neocortex. Several studies in humans have confirmed the potential of this radiotracer, however, to date, dosimetry studies of [11C]NNC-112 in humans have not been performed.

The specific objective of this protocol is to estimate radiation-absorbed doses of [11C]NNC-112 in human subjects. For this purpose, we propose to perform a kinetic whole body imaging study of [11C]NNC-112 in healthy human subjects. We hypothesize that the level of radiation-absorbed doses of [11C]NNC-112 in humans will be within limits, and consequently, we should be able to move to the next stage of our imaging research, where we will use this radioligand to measure the density and distribution of D1 receptors in Parkinson's disease.

Study Type

Interventional

Enrollment

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Mental Health (NIMH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

All subjects must be healthy and aged 18-70 years.

EXCLUSION CRITERIA

Current psychiatric disease, substance abuse or severe systemic disease based on history and physical exam

Laboratory tests with clinically significant abnormalities

More than moderate hypertension

Any prior participation in other research protocols within the past year that involve radiation, with the exception of plain radiography studies (i.e., chest x-rays).

Pregnancy and Breast Feeding

Positive HIV test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

July 27, 2004

First Submitted That Met QC Criteria

July 27, 2004

First Posted (Estimate)

July 28, 2004

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 040170
  • 04-M-0170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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