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)
This study is ongoing, but not recruiting participants.
Sponsor:
GE Healthcare
Collaborators:
H2O Clinical LLC
Quintiles, Inc.
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01952678
First received: September 19, 2013
Last updated: August 17, 2016
Last verified: August 2016
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Purpose
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 | Intervention |
|---|---|
|
Essential Tremor Parkinson's Disease |
Other: Subjects dosed in a separate study |
| Study Type: | Observational |
| Study Design: | 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) |
Resource links provided by NLM:
Further study details as provided by GE Healthcare:
Primary Outcome Measures:
- Blinded visual assessment of each subject's DaTscan image as normal or abnormal [ Time Frame: 1 day ] [ Designated as safety issue: No ]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:
- Abnormal images categorized [ Time Frame: 1 day ] [ Designated as safety issue: No ]Abnormal images will be further categorized as 1) abnormal and typical of PD, or 2) abnormal but atypical of PD.
| Estimated Enrollment: | 232 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | November 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01952678
Please refer to this study by its ClinicalTrials.gov identifier: NCT01952678
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
| Responsible Party: | GE Healthcare |
| ClinicalTrials.gov Identifier: | NCT01952678 History of Changes |
| Other Study ID Numbers: | GE-001-011 |
| Study First Received: | September 19, 2013 |
| Last Updated: | August 17, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 26, 2016