Related Experiment Video
Updated: Aug 13, 2026

Measurements of Motor Function and Other Clinical Outcome Parameters in Ambulant Children with Duchenne Muscular Dystrophy
Published on: January 12, 2019
The use of MRI as an outcome measure in clinical trials
David K B Li1, Mary Jane Li, Anthony Traboulsee
1Department of Radiology, University of British Columbia Hospital, Vancouver, Canada.
Abstract:
Because the changes on MRI likely reflect various aspects of the underlying pathology of multiple sclerosis, MRI outcome measures have become an important component of most MS clinical trials, providing objective, supportive evidence for the clinical endpoints. Although there is currently insufficient evidence to support any single or combination of MRI measures as a fully validated surrogate, it is now generally accepted that if the aim of a new therapy is to prevent relapses, new Gd-enhancing and T2 lesions can be considered an appropriate surrogate outcome measure of relapses, and MRI activity outcomes can be recommended as the primary measure of treatment efficacy.
Insights
Magnetic resonance imaging (MRI) is crucial for multiple sclerosis (MS) clinical trials. MRI activity outcomes, like new Gd-enhancing and T2 lesions, are accepted as primary efficacy measures for therapies aiming to prevent relapses.
Area of Science:
- Neurology
- Radiology
- Clinical Trials
Background:
- Multiple Sclerosis (MS) pathology is complex and impacts clinical outcomes.
- Magnetic Resonance Imaging (MRI) provides objective insights into MS pathology.
- MRI outcome measures are integral to modern MS clinical trials.
Purpose of the Study:
- To evaluate the role of MRI outcome measures in assessing treatment efficacy for Multiple Sclerosis.
- To determine the appropriateness of MRI measures as surrogate endpoints in MS clinical trials.
Main Methods:
- Review of current evidence and acceptance of MRI measures in MS clinical trials.
- Analysis of MRI metrics such as Gadolinium-enhancing (Gd) and T2 lesions.
- Comparison of MRI activity outcomes with clinical endpoints like relapses.
Main Results:
- MRI changes correlate with various aspects of MS pathology.
- New Gd-enhancing and T2 lesions are considered appropriate surrogate outcomes for relapse prevention.
- MRI activity outcomes are recommended as primary efficacy measures.
Conclusions:
- While not fully validated as surrogates, MRI measures offer objective evidence in MS trials.
- MRI activity outcomes are suitable primary endpoints for therapies targeting relapse prevention in MS.
Related Concept Videos
Magnetic Resonance Imaging
Imaging Studies for Cardiovascular System IV: CMRI
Brain Imaging
These technologies include computerized axial tomography (CAT or CT scans), positron-emission tomography (PET scans), magnetic resonance imaging (MRI), functional magnetic resonance imaging (fMRI), and Transcranial Magnetic Stimulation (TMS).
Imaging Studies IV: Magnetic Resonance Imaging
Imaging Studies I: CT and MRI
Description of the Procedures
Computed Tomography (CT) scan:
Computed Tomography (CT) scans use X-ray technology to generate detailed images of bones, organs, and tissues. During the scan, the patient lies on a moving table...