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)

NCT01952678 | Completed Results

• 1 other identifier: GE-001-011
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor; Parkinson's Disease

Keywords

DaTscan; Parkinson's Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

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

  Day 1

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

  Day 1

Study Arms (2)

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

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

Interventions

DaTscan™ - Non-Caucasian Participants OTHER

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

DaTscan™ - Non-Caucasian Participants

DaTscan™ - Caucasian Participants OTHER

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

DaTscan™- Caucasian Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-Caucasian and Caucasian Subjects With Parkinson's Disease (PD) or Essential Tremor (ET).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• H2O Clinical LLC: collaborator
• Quintiles, Inc.: collaborator

Study Sites (1)

GE Healthcare

Marlborough, Massachusetts, 01752, United States

Location

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Jose M Zubeldia, M.D.
• Organization: GE Healthcare

jose.zubeldia@ge.com

011-44-1494-543137

Study Officials

• Jose M Zubeldia, M.D.

  GE Healthcare

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 30, 2013
• Study Start: July 30, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 2, 2018
• Results First Posted: August 2, 2018

Record last verified: 2017-10

Locations

US (1)