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)

N/ACompletedNCT01952678

GE Healthcare204 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

204

Conditions

Essential Tremor Parkinson's Disease

Interventions

DaTscan™ - Non-Caucasian ParticipantsOTHER

Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.

DaTscan™ - Caucasian ParticipantsOTHER

Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

GE Healthcare

Marlborough, Massachusetts, United States

Outcomes

Primary Outcomes

Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population

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.

Time frame: Day 1

Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population

Time frame: Day 1

Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population

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.

Time frame: Day 1

Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population

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.

Data from ClinicalTrials.gov

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Secondary Outcomes

Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population

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.

Time frame: Day 1

Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population

Time frame: Day 1