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:
Collaborators:
H2O Clinical LLC
Quintiles
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01952678
First received: September 19, 2013
Last updated: January 3, 2014
Last verified: January 2014
  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: March 2015
Estimated Primary Completion Date: March 2015 (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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
H2O Clinical LLC
Quintiles
Investigators
Study Chair: Igor D Grachev, M.D., PhD GE Healthcare
  More Information

No publications provided

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: January 3, 2014
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 July 24, 2014