RecruitingNot ApplicableNCT07424027

Central Vein Sign in Multiple Sclerosis Extension Study


Sponsor

The Cleveland Clinic

Enrollment

40 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Multiple sclerosis (MS) is a common disease of the central nervous system that affects almost 1 million people in the United States. However, diagnosing MS can be difficult and often leads to misdiagnosis. More sensitive and specific biomarkers are needed to help with the diagnosis, prognosis, and evaluation of treatment response for MS. The central vein sign (CVS) and the paramagnetic rim lesion (PRL) are two biomarkers that have shown promise in improving diagnostic accuracy for MS. The goal of this study is to provide pilot information on the long-term performance of the CVS and PRL to help diagnose and follow people with MS. The study will follow 40 participants over 48 months to determine if the CVS and PRL help make a diagnosis of MS and how they can be used to follow people with MS. The study will also examine how PRL and CVS change over 48 months. The results of this pilot study will inform the development of a grant application to extend 5-year follow-up for all 420 participants of the CAVS-MS study. The study will use high-resolution T2\*-weighted MRI to detect the CVS and PRLs. An MRI of the brain with contrast will be used to examine CVS, PRL and longitudinal analysis of lesions that slowly grow over time (slowly expanding lesions \[SELs\]). The results of this study have the potential to improve the accuracy of diagnosing and treating MS.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is an extension study following people who already participated in the CAVS-MS study, which looked at a specific brain MRI marker (the central vein sign) to help diagnose multiple sclerosis. This follow-up study continues tracking participants with additional MRI scans. **You may be eligible if...** - You participated in and completed the original CAVS-MS study (including the 24-month visit) - You are able to provide written consent to continue in this extension study **You may NOT be eligible if...** - You have a contraindication to MRI (such as certain metal implants not compatible with MRI) - You are unable to tolerate MRI due to claustrophobia or uncontrollable movement such as tremor - You did not complete the original CAVS-MS study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMRI Contrast

The study will include an MRI


Locations(3)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT07424027


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