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)
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ClinicalTrials.gov Identifier: NCT01952678 |
Recruitment Status
:
Completed
First Posted
: September 30, 2013
Last Update Posted
: February 24, 2017
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Condition or disease | Intervention/treatment |
---|---|
Essential Tremor Parkinson's Disease | Other: Subjects dosed in a separate study |
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 |
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.
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Other: Subjects dosed in a separate study
The subjects in this study were dosed with DaTscan drug product in a separate study.
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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.
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- 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).
- 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.

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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 |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952678
United States, Massachusetts | |
GE Healthcare | |
Marlborough, Massachusetts, United States, 01752 |
Study Chair: | Jose M Zubeldia, M.D. | GE Healthcare |
Responsible Party: | GE Healthcare |
ClinicalTrials.gov Identifier: | NCT01952678 History of Changes |
Other Study ID Numbers: |
GE-001-011 |
First Posted: | September 30, 2013 Key Record Dates |
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 |