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NCT04495556 · ClinicalTrials.gov registry record

Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis

A clinical trial of Multiple Sclerosis, sponsored by The Cleveland Clinic.

Active
Registry status
420
Enrollment target
11
Study locations

NCT04495556: Active study of Multiple Sclerosis, sponsored by The Cleveland Clinic.

NCT04495556 is a study of Multiple Sclerosis that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 420 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (28% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04495556, a study of Multiple Sclerosis, is active but no longer recruiting, sponsored by The Cleveland Clinic.

ACTIVE NOT RECRUITING
Registry status
420 participants
Enrollment target
11
Study locations

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.

Primary Outcome

MRI will be done to assess sensitivity and specificity of the CVS for multiple sclerosis. MRI will be done at baseline or start of the study and at month 24, end of study. Central veins will be counted and lesions will be considered CVS+ using specified criteria. CVS will be determined using Select6, Select3\*, and automated lesion analysis with inclusion and exclusion of periventricular lesions.

Conditions Studied

Multiple Sclerosis

Interventions

  • DIAGNOSTIC_TEST MRI

Study Locations (11)

California

  • Cedars-Sinai Medical Center - Los Angeles
  • University of Southern California - Los Angeles

Colorado

  • University of Colorado - Aurora

Connecticut

  • Yale University - New Haven

Maryland

  • Johns Hopkins University - Baltimore

Missouri

  • Washington University in St. Louis - St Louis

Ohio

  • Cleveland Clinic Foundation - Cleveland

Pennsylvania

  • University of Pennsylvania - Philadelphia

Texas

  • The University of Texas at Austin - Austin

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 2020-06-11
Est. Completion 2027-01
The Cleveland Clinic

688 total trials

What the registry record for NCT04495556 still lists

NCT04495556 is an observational study that tracks outcomes without assigning an intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (28% lower).

The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which MRI is the first listed.

NCT04495556 lists 11 locations in 10 states (California, Colorado, Connecticut).

Frequently Asked Questions

What is clinical trial NCT04495556 about?

NCT04495556 is a clinical study titled "Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis". 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...

What is the current status of trial NCT04495556?

This trial is currently active not recruiting. The enrollment target is 420 participants. The study started on 2020-06-11. Estimated completion is 2027-01.

What conditions does trial NCT04495556 study?

This clinical trial studies the following conditions: Multiple Sclerosis.

What interventions are being tested in trial NCT04495556?

The interventions under investigation include: MRI (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT04495556?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04495556 being conducted?

This trial has 11 study locations across California, Colorado, Connecticut, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Multiple Sclerosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04495556's enrollment target sits among peer trials

420 44th of 315 higher than 272 of 315 other Multiple Sclerosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04495556, the US trial registry maintained by the National Library of Medicine. NCT04495556 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.