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)

Parkinson's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952678
• Other study ID #: GE-001-011
• Status: Completed
• Start date: July 30, 2013
• Est. completion date: May 2016

Study information

• Verified date: October 2017
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Parkinson's Disease
• Tremor

Intervention

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

Locations

Country	Name	City	State
United States	GE Healthcare	Marlborough	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
GE Healthcare	H2O Clinical LLC, Quintiles, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Primary	Positive 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 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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Secondary	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.	Day 1
Secondary	Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) 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.	Day 1