Clinical trial NCT01952678: 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)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Tremor
Parkinson's Disease
Keywords: DaTscan
Parkinson's Disease
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: H2O Clinical LLC
name: Quintiles, Inc.
First posted: 2013-09-30
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET).

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
timeFrame: Day 1
measure: Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
timeFrame: Day 1
measure: Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
timeFrame: Day 1
measure: Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
timeFrame: Day 1
Secondary outcomes:
measure: Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population
timeFrame: Day 1
measure: Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population
timeFrame: Day 1
Other outcomes:
Locations:
city: Marlborough
country: United States
facility: GE Healthcare
state: Massachusetts
Study officials:
affiliation: GE Healthcare
name: Jose M Zubeldia, M.D.
role: STUDY_CHAIR
References: