Quantitative Magnetic Resonance Imaging (MRI) Sub-Study of MS PATHS
Completed
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT04145284
- Lead Sponsor
- Biogen
- Brief Summary
The primary objective is to assess the performance of a new magnetic resonance imaging (MRI) metrics software prototype when used in radiological practice in multiple sclerosis (MS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Board-certified neuroradiologists or experienced neuroradiology fellows.
- Employed at a participating MS PATHS institution.
- At least 3 years of experience in interpreting brain MRI scans of MS participants.
Key
Exclusion Criteria
- Inability to comply with sub-study procedures.
- Other unspecified reasons that, in the opinion of Biogen or the MS PATHS Radiology Lead at the institution, make the radiologist unsuitable for participation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of Approve or Reject Decision Baseline up to 6 weeks MRIs from participants will be analyzed by the prototype. The radiologist will view the brain segmentation results and the new or enlarging T2 lesion detection results. The radiologist will either "Approve" or "Reject" the results.
Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of False-Positive and False-Negative Lesions Baseline up to 6 weeks MRIs from participants will be analyzed by the prototype. The radiologist will view the new or enlarging T2 lesions to determine false-positive or false-negative results.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇩🇪Dresden, Saxony, Germany