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NCT01952678 · ClinicalTrials.gov registry record
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)
A clinical trial of Parkinson's Disease and Essential Tremor, sponsored by GE Healthcare.
- Completed
- Registry status
- 204
- Enrollment target
- 1
- Study location
NCT01952678: Completed study of Parkinson's Disease and Essential Tremor, sponsored by GE Healthcare.
NCT01952678 is a study of Parkinson's Disease and Essential Tremor that has completed, run by GE Healthcare. The registered enrollment target is 204 participants, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01952678, a study of Parkinson's Disease and Essential Tremor, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- 204 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the
Conditions Studied
Interventions
- OTHER DaTscan™ - Non-Caucasian Participants
- OTHER DaTscan™ - Caucasian Participants
Study Locations (1)
Massachusetts
- GE Healthcare - Marlborough
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2013-07-30 |
| Est. Completion | 2016-05 |
What the finished NCT01952678 record still lists
NCT01952678 is an observational study that tracks outcomes without assigning an intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 634-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which DaTscan™ - Non-Caucasian Participants is the first listed.
NCT01952678 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01952678 about?
NCT01952678 is a clinical study titled "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)". 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.
What is the current status of trial NCT01952678?
This trial is currently completed. The enrollment target is 204 participants. The study started on 2013-07-30. Estimated completion is 2016-05.
What conditions does trial NCT01952678 study?
This clinical trial studies the following conditions: Parkinson's Disease, Essential Tremor.
What interventions are being tested in trial NCT01952678?
The interventions under investigation include: DaTscan™ - Non-Caucasian Participants (OTHER), DaTscan™ - Caucasian Participants (OTHER).
Who is sponsoring clinical trial NCT01952678?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01952678 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01952678's enrollment target sits among peer trials
204 33rd of 158 higher than 126 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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