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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04145284

Enrollment

Registered

2019-10-30

Start date

2019-04-30

Completion date

2020-04-30

Last updated

2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany, United States

Outcome results