The National Institutes of Health (NIH) awarded a $7.2 million grant to a team led by Cleveland Clinic researchers that will study whether a new biomarker might more accurately diagnose multiple sclerosis (MS).
Grant money will support a study in 400 adults suspected of having MS to determine if the proposed biomarker, called the central vein sign (CVS), is a reliable diagnostic marker for this disease.
“Up to 20% of MS diagnoses turn out to be inaccurate. Our new multicenter study aims to reduce that number by evaluating if this new biomarker can improve diagnostic accuracy and simplify clinical decision-making,” Daniel Ontaneda, MD, PhD, with the Cleveland Clinic’s Mellen Center for Multiple Sclerosis, said in a news release.
The study, called CAVS-MS, will enroll people with evidence of typical and atypical MS symptom at 11 sites across North America, overseen and coordinated by the Cleveland Clinic. It will be led by Ontaneda and Nancy Sicotte, MD, with Cedars-Sinai, and conducted under the auspices of the North American Imaging in MS Cooperative.
The area surrounding the brain’s central vessels is thought to be where inflammation more likely occurs, leading to lesions that can be detected on MRI scans. CVS refers to the visualization of these veins inside brain lesions, which is thought to reflect the loss of myelin — a protective sheath of nerve cells — due to inflammation.
CVS has been proposed as a sensitive and specific biomarker, one able to help differentiate MS from other conditions with similar brain lesions captured on imaging, from meningitis to strokes, lupus to Alzheimer’s.
A recent study showed that detecting changes to the brain’s central vein captured through MRI is a useful and accurate way to improve MS diagnoses. In the study, an analysis of more than 4,000 brain lesions — collected from eight neuroimaging European centers — showed that capturing CVS changes enabled researchers to distinguish people with MS, including those with clinically isolated syndrome, from people without this disease but comparable brain lesions.
“We aim to show that the CVS is a simple and reliable diagnostic biomarker that can be immediately translated into clinical care,” Ontaneda said. “We are evaluating if this sign can improve sensitivity and specificity relative to current approaches and streamline the clinical decision-making process.”
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