Validation of DaTscan for Detection of Parkinson Disease Related Disorders

Sponsor

Wisconsin Institute for Neurologic and Sleep Disorders S.C. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02138682

Collaborator

Wisconsin Parkinson Association (Other), Medical College of Wisconsin (Other), GE Healthcare (Industry)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Movement Disorders	Drug: l-123 Ioflupane

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: l-123 Ioflupane 5 millicuries of Ioflupane Other Names: DaTscan

Arm

Intervention/Treatment

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.

Drug: l-123 Ioflupane

5 millicuries of Ioflupane

Other Names:

DaTscan

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
2	Wisconsin Institute for Neurologic and Sleep Disorders, SC	Milwaukee	Wisconsin	United States	53233