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

April 1, 2019 updated by: Institute for Neurodegenerative Disorders

Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

500

Phase

  • Phase 2

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

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

National Institutes of Health (NIH)
Molecular NeuroImaging

Investigators

  • Principal Investigator: Kenneth Marek, MD, Institute for Neurodegenerative Disorders

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

September 1, 1992

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dopamine Transporter Imaging

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.

Clinical Trials on Parkinson's Disease

Clinical Trials on [123I]ß-CIT and SPECT imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe