Active not recruitingOBSERVATIONAL

Central Vein Sign: a Diagnostic Biomarker in Multiple Sclerosis

This study, called CAVS-MS, is investigating a new way to diagnose Multiple Sclerosis (MS) using a special feature on MRI scans called the Central Vein Sign (CVS). Currently, diagnosing MS can be tricky, and sometimes people are misdiagnosed, leading to unnecessary treatments. Also, the usual diagnostic tests don't always work well for people with unusual MS symptoms. This study hopes to show that the CVS can provide a more accurate and earlier diagnosis for a wider range of patients. It will involve looking at patients with both typical and atypical (less common) symptoms of MS to see if the CVS can help doctors tell MS apart from other conditions.

At a glance

Status

Active not recruiting

Sponsor

The Cleveland Clinic

Enrolment target

420

Start

11 Jun 2020

Estimated completion

01 Jan 2027

Multiple Sclerosis

What is this study about?

Imagine being told you have Multiple Sclerosis (MS) when you actually don't, or having MS but it takes a long time to get a proper diagnosis. Both situations can be really tough. Unfortunately, misdiagnosis or delays in diagnosis can happen with MS. Sometimes, up to 1 in 5 people initially diagnosed with MS are later found not to have the condition. This can mean they receive treatments they don't need, which can have side effects.

Our current ways of diagnosing MS, which use a mix of symptoms and special MRI scans, work well for many people, especially those with typical signs of the disease. However, nearly half of people with MS might have less common symptoms, and for them, these criteria aren't as helpful. Also, an early diagnosis is really important for MS so that treatment can start sooner and potentially prevent long-term problems.

This study, called CAVS-MS, is looking at a new tool to improve MS diagnosis. It's focusing on something seen on MRI scans called the "Central Vein Sign" (CVS). Researchers believe that seeing this sign could make diagnosing MS much more accurate and easier, even for people with unusual symptoms. The study will involve a large group of patients across North America, some with typical MS symptoms and others with symptoms that are harder to pinpoint, to see if the CVS can help make a clearer and quicker diagnosis.

Key takeaways

This study aims to improve MS diagnosis accuracy.
It uses a new MRI feature called the Central Vein Sign (CVS).
It's helpful for people with both typical and unusual MS symptoms.
Better diagnosis can prevent misdiagnosis and unnecessary treatments.
Early diagnosis of MS is important for starting treatment sooner.

Who may be eligible?

This study is looking for adults aged 18 to 65 years old. You might be suitable if your doctor suspects you have MS and has referred you for further checks.

There are two main groups being looked at. One group is for people presenting with typical MS symptoms, such as problems with vision in one eye, double vision, numbness or tingling, or weakness in a limb, among others. The second group is for those with less common symptoms that could still suggest MS, like vision problems in both eyes, persistent nausea, or memory issues, or even if an MRI scan suggests MS but you don't have any major symptoms yet.

Crucially, you would need to be able to understand the study and agree in writing to take part. For some participants, previous MRI scans might be needed, ideally within three months of your symptoms starting.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Has a doctor referred you with a suspicion of MS?
Do you have typical or unusual symptoms that might be MS, or have MRI findings suggestive of MS without clear symptoms?
Are you able to provide written consent to participate?
Do you have digital MRI scans available from within the last 3 months, if already started on MS medication?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not provided in this summary. However, generally, participation in a study like this would likely involve having special MRI scans to look for the Central Vein Sign, and possibly some follow-up appointments to track your health over time. You would not typically be given a new medication in this type of study, as it's focused on improving diagnosis.

The research will look at your existing health information and new scans. The exact number of visits and the total duration of your participation would be explained fully by the study team, but it's common for studies involving MRI to have at least one or two scan appointments.

Potential risks and benefits

Taking part in this study could potentially help improve how MS is diagnosed in the future, leading to more accurate diagnoses and earlier treatment for others. For you personally, it won't change your current medical care, but it might offer some reassurance or clarity as the research progresses. The main risk involves having MRI scans, which are generally very safe but do involve lying still in a scanner. You would have the right to withdraw from the study at any time without affecting your medical care.

Locations (11)

Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States
University of Southern California
Verified postcode
Los Angeles, United States
University of Colorado
Verified postcode
Aurora, United States
Yale University
Verified postcode
New Haven, United States
Johns Hopkins University
Verified postcode
Baltimore, United States
Washington University in St. Louis
Verified postcode
St Louis, United States
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States
University of Pennsylvania
Verified postcode
Philadelphia, United States
The University of Texas at Austin
Verified postcode
Austin, United States
University of Vermont
Verified postcode
Burlington, United States
St. Michael's Hospital of Unity Health Toronto
Verified postcode
Toronto, Canada

Common questions

What is the Central Vein Sign (CVS)?

The Central Vein Sign (CVS) is a specific pattern that doctors can see on special MRI scans within brain lesions, which may help them tell if the lesions are caused by MS.

Why is it important to diagnose MS accurately?

An accurate diagnosis means you get the right treatment for your condition. A wrong diagnosis can lead to unnecessary treatments with potential side effects, or a delay in getting the correct MS treatment.

Will this study change my current MS treatment?

No, this study is focused on improving diagnostic methods, not on testing new treatments. Your current medical care and treatment plan will not be affected by your participation.

What if I have unusual symptoms that doctors aren't sure about?

This study is specifically designed to help people with both typical and atypical (unusual) symptoms that might be MS. It aims to make diagnosis clearer in these challenging cases.

Do I have to take part if I'm asked?

No, taking part in any research study is always completely your choice, and you can decide not to participate or withdraw at any time without it affecting your medical care.