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)

• 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: GE Healthcare
• Collaborators: H2O Clinical LLC; Quintiles, Inc.
• Information provided by (Responsible Party): GE Healthcare

Study Description

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

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Massachusetts

GE Healthcare

Marlborough, Massachusetts, United States, 01752

Sponsors and Collaborators

GE Healthcare

H2O Clinical LLC

Quintiles, Inc.

Investigators

• Study Chair: Jose M Zubeldia, M.D.; GE Healthcare

More Information

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01952678
• Other Study ID Numbers: GE-001-011
• First Posted: September 30, 2013
• 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:

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