NCT07424027 · The Cleveland Clinic
Central Vein Sign in Multiple Sclerosis Extension Study
What this study is about
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.
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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.
Interventions
DIAGNOSTIC_TEST
MRI Contrast
The study will include an MRI
Primary outcome measures
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.
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.
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.
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.
Clinical Outcomes- Diagnosis of MS by 2017 Diagnostic Criteria
Time frame: McDonald criteria will be reviewed at Month 48.
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.
Clinical Outcomes- EDSS
Time frame: EDSS will be assessed at the Month 48 visit.
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.
Clinical Outcomes- Multiple Sclerosis Functional Composite (MSFC-4)
Time frame: MSFC-4 will be assessed at the Month 48 visit.
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
- Cleveland, Ohio
- Philadelphia, Pennsylvania
Collaborators
Cedars-Sinai Medical Center, University of Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations