Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07424027

Central Vein Sign in Multiple Sclerosis Extension Study

Led by The Cleveland Clinic · Updated on 2026-02-20

40

Participants Needed

3

Research Sites

116 weeks

Total Duration

On this page

Sponsors

T

The Cleveland Clinic

Lead Sponsor

C

Cedars-Sinai Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Central Vein Sign in Multiple Sclerosis Extension Study

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be enrolled in and meet all inclusion criteria of the CAVS-MS study.
  • Must have participated in the CAVS-MS study and have completed month 24 visits.
  • Able to provide written informed consent to participate in the study.
Not Eligible

You will not qualify if you...

  • Contraindication to MRI studies; metal or metal implants incompatible with MRI.
  • Inability to tolerate MRI due to claustrophobia or known excessive movement (e.g., tremor).

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Not Yet Recruiting

2

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

3

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Not Yet Recruiting

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Research Team

M

Meghan Kilbane

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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