Central Vein Sign in Multiple Sclerosis Extension Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
The Cleveland Clinic
Study ID
NCT07424027
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MRI Contrast — DIAGNOSTIC_TEST
    The study will include an MRI

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Confirmed diagnosis of MS at the end of the CAVS-MS study
  • Experimental: Unconfirmed diagnosis of MS (at risk for MS) at the end of the CAVS-MS study

Primary Outcome Measure

MRI Outcomes- CVS [ Time Frame: Change assessed over 48 months. Scans done in the CAVS-MS core study (Baseline and Month 24) will be compared to scan done at Month 48. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Cleveland Clinic FoundationClevelandOhio44195
Dawn Maniawski
[email protected]
216 636-9196
Daniel Ontaneda, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Russell Shinohara (PRINCIPAL_INVESTIGATOR)
Matthew Schindler (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Cedars-Sinai Medical Center· Los Angeles, CACleveland Clinic Foundation· Cleveland, OHUniversity of Pennsylvania· Philadelphia, PA

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