Validation of DaTscan for Detection of Parkinson Disease Related Disorders

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02138682

Enrollment

Registered

2014-05-14

Start date

2014-07-31

Completion date

Unknown

Last updated

2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Movement Disorders, Parkinson Disease

Keywords

DaT-SPECT scan, Parkinson's, Diagnostic

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.

Interventions

DRUGl-123 Ioflupane

5 millicuries of Ioflupane

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026