Long-term follow-up of MRI markers (central vein sign and paramagnetic rim lesions) in multiple sclerosis
Central Vein Sign in Multiple Sclerosis Extension Study
This project will test whether two MRI markers—the central vein sign (CVS) and paramagnetic rim lesions (PRL)—help diagnose and track people with multiple sclerosis over 48 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT07424027 on ClinicalTrials.gov |
What this trial studies
This is a 48-month extension of the CAVS‑MS effort that will follow 40 participants at three U.S. centers to collect serial MRIs and compare CVS and PRL findings over time. Participants who completed the 24‑month CAVS‑MS visit will undergo additional MRI visits, including contrast-enhanced sequences, to document lesion characteristics and changes. The study will measure how well CVS helps distinguish MS lesions from mimics and whether PRLs predict clinical course or lesion evolution. Results will provide pilot longitudinal data to inform a larger multicenter follow-up effort.
Who should consider this trial
Good fit: Adults with suspected or confirmed multiple sclerosis who completed the original CAVS‑MS two‑year visits, can give informed consent, and can safely undergo MRI are the intended participants.
Not a fit: People who did not participate in the original CAVS‑MS, who have MRI contraindications (e.g., incompatible metal implants), or who cannot tolerate MRI (severe claustrophobia or excessive movement) are not eligible and are unlikely to benefit from this extension.
Why it matters
Potential benefit: If successful, these MRI markers could make diagnosis more accurate and help doctors monitor disease activity over time, which may lead to earlier or better-tailored treatment.
How similar studies have performed: Numerous cross-sectional studies have shown the CVS reliably distinguishes MS lesions from common mimics and PRLs are a promising marker, but long-term longitudinal data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Los Angeles, California and 2 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Not_yet_recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Daniel Ontaneda, MD, PHD — The Cleveland Clinic
- Study coordinator: Meghan Kilbane
- Email: kilbanm@ccf.org
- Phone: 216-445-9845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.