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Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis
Sponsor: The Cleveland Clinic
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
Conditions
Interventions
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