Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome
Primary Purpose
Parkinson's Disease, Parkinsonian Syndrome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
[123I]ß-CIT and SPECT imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease focused on measuring parkinson, diagnosis
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00132626
First Posted
August 18, 2005
Last Updated
April 1, 2019
Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Molecular NeuroImaging, National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00132626
Brief Title
Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome
Official Title
Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Molecular NeuroImaging, National Institutes of Health (NIH)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Parkinsonian Syndrome
Keywords
parkinson, diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
[123I]ß-CIT and SPECT imaging
Primary Outcome Measure Information:
Title
CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
Secondary Outcome Measure Information:
Title
Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Marek, MD
Organizational Affiliation
Institute for Neurodegenerative Disorders
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome
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