Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome

This study has been completed.

First Received: August 18, 2005 Last Updated: February 20, 2007 History of Changes

Sponsors and Collaborators:	Institute for Neurodegenerative Disorders Molecular NeuroImaging National Institutes of Health (NIH)
Information provided by:	Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:	NCT00132626

Purpose

This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in research participants with Parkinson's disease.

Condition	Intervention	Phase
Parkinson's Disease Parkinsonian Syndrome	Procedure: [123I]ß-CIT and SPECT imaging	Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism

Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:

CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness

Secondary Outcome Measures:

Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred

Estimated Enrollment:	500
Study Start Date:	September 1992
Estimated Study Completion Date:	August 2005

Detailed Description:

The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.

After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain.

Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 21 years of age
Normal screening laboratory studies
At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment

Exclusion Criteria:

Pregnancy
Significant medical disease including abnormalities found on screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132626

Sponsors and Collaborators

Institute for Neurodegenerative Disorders

Molecular NeuroImaging

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Kenneth Marek, MD

Institute for Neurodegenerative Disorders

More Information

No publications provided

Study ID Numbers:	Dopamine Transporter Imaging
Study First Received:	August 18, 2005
Last Updated:	February 20, 2007
ClinicalTrials.gov Identifier:	NCT00132626 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:

parkinson
diagnosis

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Pathologic Processes
Disease
Movement Disorders
Parkinson Disease
Syndrome
Nervous System Diseases

Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 07, 2009