Validation of DaTscan for Detection of Parkinson Disease Related Disorders
- Conditions
- Parkinson DiseaseMovement Disorders
- Interventions
- Drug: l-123 Ioflupane
- Registration Number
- NCT02138682
- Lead Sponsor
- Wisconsin Institute for Neurologic and Sleep Disorders S.C.
- Brief Summary
This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- aged 75 or older
- sporadic late onset Parkinson disease or one of its variants
- registered in tissue donation program
- aged less than 75 years old
- mental status preventing neuroimaging or transportation to site
- inability to remain "relatively steady" during the scanning procedure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description l-123 Ioflupane l-123 Ioflupane Study group includes those clinically diagnosed with Parkinson disease who are aged 75 and older who have agreed to donate brain tissue at time of death and are able to participate in the imaging scan process.
- Primary Outcome Measures
Name Time Method Consistency Between Diagnostic Procedures Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment. Consistency of diagnosis between: (1) clinical diagnosis, (2) scan results, and (3) pathological results.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Wisconsin Institute for Neurologic and Sleep Disorders, SC
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States