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)



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:8/4/2018
Start Date:July 30, 2013
End Date:May 2016

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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)

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.


Inclusion Criteria:

For Non-Caucasians:

- Non-Caucasian male and female adult participants (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 participant's final clinical diagnosis of PD or ET.

- The participant had existing diagnostic-quality and interpretable DaTscan SPECT images
of the brain.

For Caucasians:

- Caucasian male and female adult participants (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 participant's final clinical diagnosis of PD or ET.

- The participant had existing diagnostic-quality and interpretable DaTscan SPECT images
of the brain.

- The participant was matched by final clinical diagnosis, sex and age (±5 years) with a
non-Caucasian participant.

Exclusion Criteria:

- Known/suspected structural abnormalities of the brain (e.g., hydrocephalus; brain
tumor; stroke; etc.) that could grossly distort the DaTscan images.

- Participants whose race and ethnic information could not be determined from source
document review.
We found this trial at
1
site
Marlborough, Massachusetts 01752
618
mi
from 43215
Marlborough, MA
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