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

NCT00088517 | Completed Phase 1

• 2 other identifiers: 04017004-M-0170
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Biodistribution; MIRD; Radiation Absorbed Dose; Healthy; Prefrontal Cortex; Radiation Exposure; PET; Dopamine D1 Receptor; (11C)NNC-112; Healthy Volunteer; HV

Interventions

[11C]NNC-112 DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Abi-Dargham A, Martinez D, Mawlawi O, Simpson N, Hwang DR, Slifstein M, Anjilvel S, Pidcock J, Guo NN, Lombardo I, Mann JJ, Van Heertum R, Foged C, Halldin C, Laruelle M. Measurement of striatal and extrastriatal dopamine D1 receptor binding potential with [11C]NNC 112 in humans: validation and reproducibility. J Cereb Blood Flow Metab. 2000 Feb;20(2):225-43. doi: 10.1097/00004647-200002000-00003.

  PMID: 10698059 BACKGROUND

• Abi-Dargham A, Mawlawi O, Lombardo I, Gil R, Martinez D, Huang Y, Hwang DR, Keilp J, Kochan L, Van Heertum R, Gorman JM, Laruelle M. Prefrontal dopamine D1 receptors and working memory in schizophrenia. J Neurosci. 2002 May 1;22(9):3708-19. doi: 10.1523/JNEUROSCI.22-09-03708.2002.

  PMID: 11978847 BACKGROUND

• Andersen PH, Gronvald FC, Hohlweg R, Hansen LB, Guddal E, Braestrup C, Nielsen EB. NNC-112, NNC-687 and NNC-756, new selective and highly potent dopamine D1 receptor antagonists. Eur J Pharmacol. 1992 Aug 14;219(1):45-52. doi: 10.1016/0014-2999(92)90578-r.

  PMID: 1397049 BACKGROUND

Study Design

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

Study Record Dates

• First Submitted: July 27, 2004
• First Posted: July 28, 2004
• Study Start: July 1, 2004
• Study Completion: March 1, 2006
• Last Updated: March 4, 2008

Record last verified: 2006-03

Locations

US (1)