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OpenTrials
Completed

NCT Number: NCT04145284

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

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Dresden, Saxony, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2019
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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