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ACTIVE NOT RECRUITING
NCT04495556

Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

The need for improved diagnostic methods in Multiple Sclerosis (MS) is widely recognized. Although Magnetic Resonance Imaging (MRI) is a longstanding tool for detecting MS lesions, diagnostic inaccuracies persist. Up to 20% of people diagnosed with MS (1 in 5) are later found not to have the disease. This is highly consequential, as more than two-thirds of misdiagnosed patients are unnecessarily exposed to risks from disease-modifying therapies, which in rare cases can be life-threatening. Moreover, the current standard in MS diagnosis - the McDonald criteria, which combine clinical symptoms and MRI findings - were developed from studies in people with typical clinical presentations of MS. This reduces the specificity of these criteria, rendering them uninformative for the nearly half of MS patients who present to neurologists with atypical or nonclassical symptoms. Timeliness of MS diagnosis is also key, as diagnostic delay is common in cases of relapsing-remitting MS and can carry severe and lifelong consequences. The CentrAl Vein Sign in MS (CAVS-MS) study has been designed to assess whether Central Vein Sign (CVS) criteria can help address some of these unmet diagnostic needs. It will specifically explore the role of presentation type by enrolling a mixed population of patients with typical clinical presentations (n = 200) and those with atypical presentations, including suggestive MRI findings in the absence of neurologic symptoms (n = 200) across North America.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

420

Start Date

2020-06-11

Completion Date

2027-01

Last Updated

2025-10-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

MRI

The study will include MRI at baseline (first study visit) and month 24 (final study visit). MRI at month 24 (end of study) will be used to determine McDonald Criteria and final review of CVS.

Locations (11)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Johns Hopkins University

Baltimore, Maryland, United States

Washington University in St. Louis

St Louis, Missouri, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The University of Texas at Austin

Austin, Texas, United States

University of Vermont

Burlington, Vermont, United States

St. Michael's Hospital of Unity Health Toronto

Toronto, Ontario, Canada