NCT07424027

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
19mo left

Started Oct 2025

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Oct 2025Dec 2027

Study Start

First participant enrolled

October 7, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

February 11, 2026

Last Update Submit

February 18, 2026

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisMSMRIcentral vein signCVSDiagnostic biomarkerautoimmune disease

Outcome Measures

Primary Outcomes (5)

  • MRI Outcomes- CVS

    An MRI will be done at the Month 48 visit. Central veins will be counted and lesions will be considered CVS+ using specified criteria. CVS will be determined using Select6, Select3\* by already trained raters from the core CAVS-MS study and using automated lesion analysis.

    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.

  • MRI Outcomes- PRL

    An MRI will be done at the Month 48 visit. Periventricular rim lesions (PRL) will be counted using specified criteria by already trained raters from the CAVS-MS core study and using automated lesion analysis. The automated lesions analysis will also determine lesion volume and RIM volume.

    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.

  • Clinical Outcomes- Diagnosis of MS by 2017 Diagnostic Criteria

    Determination of a diagnosis of MS using the McDonald Criteria 2017 will be conducted by a central adjudication committee. McDonald diagnostic criteria for MS are clinical, radiographic, and laboratory criteria used in the diagnosis of multiple sclerosis. Members of the adjudication committee will separately review the clinical data, laboratory testing, and study MRIs of each participant at Month 48.

    McDonald criteria will be reviewed at Month 48.

  • Clinical Outcomes- EDSS

    The Expanded Disability Status Scale (EDSS) is a standardized assessment that will be used to measure the degree of disability due to MS using a 0-10 scale. 0 meaning no disability and 10 meaning death due to MS.

    EDSS will be assessed at the Month 48 visit.

  • Clinical Outcomes- Multiple Sclerosis Functional Composite (MSFC-4)

    The MSFC-4 is group of standardized assessments that are used to measure the degree of disability due to MS. The z-scores for the tests are averaged to create the final MSFC score. A higher score indicates better function. These assessments include: Timed 25 Foot Walk (lower extremity function) 9-Hole Peg Test (upper extremity function) Symbol Digit Modalities Test (processing speed) Low-Contrast Letter Acuity (visual function)

    MSFC-4 will be assessed at the Month 48 visit.

Study Arms (2)

Confirmed diagnosis of MS at the end of the CAVS-MS study

EXPERIMENTAL
Diagnostic Test: MRI Contrast

Unconfirmed diagnosis of MS (at risk for MS) at the end of the CAVS-MS study

EXPERIMENTAL
Diagnostic Test: MRI Contrast

Interventions

MRI ContrastDIAGNOSTIC_TEST

The study will include an MRI

Confirmed diagnosis of MS at the end of the CAVS-MS studyUnconfirmed diagnosis of MS (at risk for MS) at the end of the CAVS-MS study

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

NOT YET RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Multiple SclerosisAutoimmune Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesImmune System Diseases

Study Officials

  • Daniel Ontaneda, MD, PHD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Pascal Sati, PHD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan Kilbane

CONTACT

216-445-9845kilbanm@ccf.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Neurologist, Mellen Center for Multiple Sclerosis

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 20, 2026

Study Start

October 7, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

US(3)