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

NCT04145284 | Completed

• 1 other identifier: 888MS007
• Study Type: observational
• Target: 6
• Locations: 2 countries
• Sites: 2

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline up to 6 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is the cohort of radiologists.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

Research Site

Cleveland, Ohio, 44195, United States

Location

Research Site

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 30, 2019
• Study Start: April 30, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); US (1)