N/A
Completed N=204
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)
Source: ClinicalTrials.gov NCT01952678 ↗Enrolled (actual)
204
Serious AEs
—
Results posted
Aug 2018
Primary outcomePrimary: Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population — 86.0; 84.2; 78.9; 86.0 Positive percent agreement — p=1.0000
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population |
86.0; 84.2; 78.9; 86.0; 89.5; 87.7 | 1.0000 |
| PRIMARY Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population |
85.7; 83.9; 78.6; 85.7; 89.3; 87.5 | 1.0000 |
| PRIMARY Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population |
93.0; 93.0; 84.1; 83.7; 86.4; 88.4 | 1.0000 |
| PRIMARY Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population |
92.5; 92.5; 90.2; 85.0; 90.2; 90.0 | 1.0000 |
| SECONDARY Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population |
89.0; 88.0; 81.2; 85.0; 88.1; 88.0 | 1.0000 |
| SECONDARY Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population |
88.5; 87.5; 83.5; 85.4; 89.7; 88.5 | 1.0000 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01952678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.