Recruiting

Biomarkers for MS

Sponsor:

The Cleveland Clinic

Code:

NCT07424027

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

MRI Contrast

Study Details

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.

Conditions

Multiple Sclerosis

Study ID

NCT07424027

Start date

Oct 7, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

MRI Contrast

The study will include an MRI

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. ]
  • MRI Outcomes- PRL [ 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. ]
  • Clinical Outcomes- Diagnosis of MS by 2017 Diagnostic Criteria [ Time Frame: McDonald criteria will be reviewed at Month 48. ]
  • Clinical Outcomes- EDSS [ Time Frame: EDSS will be assessed at the Month 48 visit. ]
  • Clinical Outcomes- Multiple Sclerosis Functional Composite (MSFC-4) [ Time Frame: MSFC-4 will be assessed at the Month 48 visit. ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Daniel Ontaneda, MD, PhD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • multiple sclerosis
  • MS
  • MRI
  • central vein sign
  • CVS
  • Diagnostic biomarker
  • autoimmune disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-02-20.