Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 500
- Primary Endpoint
- CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
Secondary Outcomes
- Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred