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Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis

NCT04495556 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 420

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Pennsylvania

    collaborator OTHER

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Daniel Ontaneda, MD, PhD · The Cleveland Clinic

  • Nancy Sicotte, MD · Cedars-Sinai Medical Center

  • Pascal Sati, PhD · Cedars-Sinai Medical Center

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-11
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495556 on ClinicalTrials.gov