Quantitative Magnetic Resonance Imaging (MRI) Sub-Study of MS PATHS

Biogen6 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Key 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.

Locations (2)

Research Site

Cleveland, Ohio, United States

Research Site

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of Approve or Reject Decision

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.

Time frame: Baseline up to 6 weeks

Radiologist Assessment of the Performance of the MS MRI Metrics Software Prototype by the Number of False-Positive and False-Negative Lesions

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.

Time frame: Baseline up to 6 weeks

Data from ClinicalTrials.gov

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