Overview

This trial is active, not recruiting.

Conditions essential tremor, parkinson's disease
Treatment subjects dosed in a separate study
Sponsor GE Healthcare
Collaborator H2O Clinical LLC
Start date August 2013
End date November 2016
Trial size 232 participants
Trial identifier NCT01952678, GE-001-011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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.
subjects dosed in a separate study
The subjects in this study were dosed with DaTscan drug product in a separate study.
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.
subjects dosed in a separate study
The subjects in this study were dosed with DaTscan drug product in a separate study.

Primary Outcomes

Measure
Blinded visual assessment of each subject's DaTscan image as normal or abnormal
time frame: 1 day

Secondary Outcomes

Measure
Abnormal images categorized
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by GE Healthcare.