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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00088517
First received: July 27, 2004
Last updated: March 3, 2008
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: [11C]NNC-112
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Whole Body Study of [11C]NNC-112 PET Imaging of Dopamine D1 Receptors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 10
Study Start Date: July 2004
Estimated Study Completion Date: March 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088517

Locations
United States, Maryland
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00088517     History of Changes
Other Study ID Numbers: 040170, 04-M-0170
Study First Received: July 27, 2004
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Biodistribution
MIRD
Radiation Absorbed Dose
Healthy
Prefrontal Cortex
Radiation Exposure
PET
Dopamine D1 Receptor
(11C)NNC-112
Healthy Volunteer
HV

Additional relevant MeSH terms:
Dopamine
Dopamine Agents
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 23, 2014