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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
Results First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
H2O Clinical LLC
Quintiles, Inc.
Information provided by (Responsible Party):
GE Healthcare

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.

Condition or disease Intervention/treatment
Essential Tremor Parkinson's Disease Other: DaTscan™ - Non-Caucasian Participants Other: DaTscan™ - Caucasian Participants

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Study Type : Observational
Actual Enrollment : 204 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 : July 30, 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
DaTscan™ - Non-Caucasian Participants
Non-Caucasian participants previously administered DaTscan™, 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.
Other: DaTscan™ - Non-Caucasian Participants
Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.

DaTscan™- Caucasian Participants
Caucasian participants previously administered DaTscan™, 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.
Other: DaTscan™ - Caucasian Participants
Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.




Primary Outcome Measures :
  1. Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population [ Time Frame: Day 1 ]
    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 assessment.

  2. Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population [ Time Frame: Day 1 ]
    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 assessment.

  3. Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population [ Time Frame: Day 1 ]
    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 negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.

  4. Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population [ Time Frame: Day 1 ]
    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 negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.


Secondary Outcome Measures :
  1. Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population [ Time Frame: Day 1 ]
    Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.

  2. Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population [ Time Frame: Day 1 ]
    Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
GE Healthcare
Marlborough, Massachusetts, United States, 01752
Sponsors and Collaborators
GE Healthcare
H2O Clinical LLC
Quintiles, Inc.
Investigators
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Study Chair: Jose M Zubeldia, M.D. GE Healthcare
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01952678    
Other Study ID Numbers: GE-001-011
First Posted: September 30, 2013    Key Record Dates
Results First Posted: August 2, 2018
Last Update Posted: August 2, 2018
Last Verified: October 2017
Keywords provided by GE Healthcare:
DaTscan
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations