Validation of DaTscan for Detection of Parkinson Disease Related Disorders

Parkinson Disease Clinical Trial

Official title:

Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02138682
• Other study ID #: 12-DAT-014
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: April 24, 2014
• Last updated: July 15, 2014
• Start date: July 2014

Study information

• Verified date: July 2014
• Source: Wisconsin Institute for Neurologic and Sleep Disorders S.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• aged 75 or older

• sporadic late onset Parkinson disease or one of its variants

• registered in tissue donation program

Exclusion Criteria:

• 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Movement Disorders
• Parkinson Disease

Intervention

Drug:
• l-123 Ioflupane
5 millicuries of Ioflupane

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Wisconsin Institute for Neurologic and Sleep Disorders, SC	Milwaukee	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
Wisconsin Institute for Neurologic and Sleep Disorders S.C.	GE Healthcare, Medical College of Wisconsin, Wisconsin Parkinson Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistency Between Diagnostic Procedures	Consistency of diagnosis between: (1) clinical diagnosis, (2) scan results, and (3) pathological results.	Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.	No