40 Participants NeededMy employer runs this trial

MRI Contrast for Multiple Sclerosis

Recruiting at 2 trial locations
MK
Overseen ByMeghan Kilbane
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

PS

Pascal Sati, PHD

Principal Investigator

Cedars-Sinai Medical Center

DO

Daniel Ontaneda, MD, PHD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial MRI and clinical assessments to establish baseline measurements for CVS and PRL

1 visit

Follow-up

Participants are monitored for changes in CVS and PRL over 48 months using MRI and clinical assessments

48 months
Visits at Baseline, Month 24, and Month 48

Extension

Potential extension to 5-year follow-up for further evaluation of CVS and PRL

12 months

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Unconfirmed diagnosis of MS (at risk for MS) at the end of the CAVS-MS studyExperimental Treatment1 Intervention
Group II: Confirmed diagnosis of MS at the end of the CAVS-MS studyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials
1,072
Recruited
1,377,000+

Cedars-Sinai Medical Center

Collaborator

Trials
523
Recruited
165,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+