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

Multiple Sclerosis Clinical Trial

Official title:

Performance and Feasibility of Quantitative MRI Metrics in Routine Radiology Practice: A Sub-Study of MS PATHS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04145284
• Other study ID #: 888MS007
• Status: Completed
• Start date: April 30, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: March 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
Germany	Research Site	Dresden	Saxony
United States	Research Site	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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