Compare Rates of Agreement Between Clinical Diagnosis and Visual Assessment of DaTscan™ Images in Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The primary objective of this study is to determine if the diagnostic performance of DaTscan™ single photon emission computed tomography (SPECT) imaging is different in non-Caucasian subjects compared with Caucasian subjects with movement disorders.

Condition or disease	Intervention/treatment
Essential Tremor; Parkinson's Disease	Other: Subjects dosed in a separate study

Study Design

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Study Type :	Observational
Estimated Enrollment :	232 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	A Retrospective Clinical Study to Compare the Rates of Agreement Between Clinical Diagnosis and Visual Assessment of DaTscan™ Images in Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET)
Study Start Date :	August 2013
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	May 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Non-Caucasian; Non-Caucasian male and female adult subjects (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the subject's final clinical diagnosis of PD or ET.	Other: Subjects dosed in a separate study; The subjects in this study were dosed with DaTscan drug product in a separate study.
Caucasian; Caucasian male and female adult subjects (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the subject's final clinical diagnosis of PD or ET.	Other: Subjects dosed in a separate study; The subjects in this study were dosed with DaTscan drug product in a separate study.

Outcome Measures

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Primary Outcome Measures :

1. Blinded visual assessment of each subject's DaTscan image as normal or abnormal [ Time Frame: 1 day ]
   Blinded visual assessment of each subject's DaTscan™ image as normal or abnormal by majority interpretation in the Blinded Image Evaluation (BIE).

Secondary Outcome Measures :

1. Abnormal images categorized [ Time Frame: 1 day ]
   Abnormal images will be further categorized as 1) abnormal and typical of PD, or 2) abnormal but atypical of PD.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET).

Criteria

Inclusion Criteria:

For Non-Caucasians:

• Non-Caucasian male and female adult subjects (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the subject's final clinical diagnosis of PD or ET.
• The subject has existing diagnostic-quality and interpretable DaTscan SPECT images of the brain.

For Caucasians:

• Caucasian male and female adult subjects (greater than or equal to 18 years of age) with an initial diagnosis of suspected PD or ET who underwent DaTscan SPECT imaging to assist with the subject's final clinical diagnosis of PD or ET.
• The subject has existing diagnostic-quality and interpretable DaTscan SPECT images of the brain.
• The subject is matched by final clinical diagnosis, sex and age (±5 years) with a non-Caucasian subject.

Exclusion Criteria:

• Known/suspected structural abnormalities of the brain (e.g., hydrocephalus; brain tumor; stroke; etc.) that can grossly distort the DaTscan images.
• Subjects whose race and ethnic information cannot be determined from source document review.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Massachusetts
GE Healthcare
Marlborough, Massachusetts, United States, 01752

Sponsors and Collaborators

GE Healthcare

H2O Clinical LLC

Quintiles, Inc.

Investigators

Study Chair:	Jose M Zubeldia, M.D.	GE Healthcare

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT01952678 History of Changes
Other Study ID Numbers:	GE-001-011
First Posted:	September 30, 2013
Last Update Posted:	February 24, 2017
Last Verified:	August 2016

Keywords provided by GE Healthcare:

DaTscan; Parkinson's Disease

Additional relevant MeSH terms:

Parkinson Disease; Tremor; Essential Tremor; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases	Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms