Central Vein Sign in Multiple Sclerosis Extension Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 48 months
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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 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 \[SELs\])."
- "This study will be leveraged on the Central Vein Sign: A Diagnostic Biomarker in Multiple Sclerosis (CAVS-MS)" (IRB 20-063) which is an NIH-supported (1U01NS116776-01), 2-year, prospective, international, multicenter study conducted by the North American Imaging in MS Cooperative (NAIMS) to evaluate CVS as an MRI-based diagnostic biomarker for immediate translation into clinical care."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether two signs seen on brain MRI scans can help doctors diagnose and track multiple sclerosis (MS) over time. MS is a disease of the brain and spinal cord. The study will follow 40 people from the CAVS-MS study for 48 months.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be enrolled in the CAVS-MS study and meet all of its entry rules.
- You must have finished the month 24 visits in the CAVS-MS study.
- You must be able to give written consent, meaning you understand and agree to join the study.
Who can't join
- You cannot safely have an MRI, such as because you have metal or metal implants that are not safe for MRI.
- You cannot handle an MRI because of fear of tight spaces or too much movement, such as shaking.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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).
Study sites (3)
CA
- Cedars-Sinai Medical Center · Los Angeles, CA 90048More trials in Los Angeles
OH
- Cleveland Clinic Foundation · Cleveland, OH 44195Dawn Maniawski · Study contact · 216 636-9196 · MANIAWD@ccf.orgDaniel Ontaneda, MD, PhD · Principal investigatorMore trials in Cleveland
PA
- University of Pennsylvania · Philadelphia, PA 19104Russell Shinohara · Principal investigatorMatthew Schindler · Sub-investigatorMore trials in Philadelphia