Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial
Autor: | Jiwon Oh, Erin E. Longbrake, Nicholas Illenberger, Peter A. Calabresi, D Moreno-Dominguez, Praneeta C. Raza, Enrique Alvarez, Christina J. Azevedo, J. A. Cohen, Matthew K. Schindler, P Rodrigues, Marwa Kaisey, Ellen M. Mowry, E Gombos, M Ramos, N Mitra, M Kilbane, Daniel S. Reich, Gary Cutter, Salim Chahin, Roland G. Henry, Andrew J. Solomon, Russell T. Shinohara, Emmanuelle Waubant, Nancy L. Sicotte, Pascal Sati, Daniel Ontaneda, L Freeman |
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Rok vydání: | 2021 |
Předmět: |
Demyelinating disease
medicine.medical_specialty Cognitive Neuroscience Concordance Computer applications to medicine. Medical informatics R858-859.7 T2*-weighted imaging Fluid-attenuated inversion recovery Multiple sclerosis fluids and secretions Multicenter trial Diagnosis medicine Humans Multicenter Studies as Topic Radiology Nuclear Medicine and imaging Prospective Studies RC346-429 Protocol (science) business.industry Regular Article McDonald criteria Susceptibility-weighted imaging Biomarker Central vein equipment and supplies medicine.disease Magnetic Resonance Imaging Cross-Sectional Studies Neurology Susceptibility weighted imaging cardiovascular system Biomarker (medicine) Neurology. Diseases of the nervous system Neurology (clinical) Radiology business Biomarkers MRI |
Zdroj: | NeuroImage: Clinical, Vol 32, Iss, Pp 102834-(2021) NeuroImage : Clinical |
ISSN: | 2213-1582 |
Popis: | Highlights • Approximately one in five patients with MS do not have the disease. • The central vein differentiates multiple sclerosis from other white matter lesions. • The central vein sign has not been evaluated in multi-center prospective studies. • CAVS-MS is a prospective multicenter study to validate the central vein. • CAVS-MS will useT2*-weighted, high-isotropic-resolution, segmented echo-planar MRI. The specificity and implementation of current MRI-based diagnostic criteria for multiple sclerosis (MS) are imperfect. Approximately 1 in 5 of individuals diagnosed with MS are eventually determined not to have the disease, with overreliance on MRI findings a major cause of MS misdiagnosis. The central vein sign (CVS), a proposed MRI biomarker for MS lesions, has been extensively studied in numerous cross sectional studies and may increase diagnostic specificity for MS. CVS has desirable analytical, measurement, and scalability properties. “Central Vein Sign: A Diagnostic Biomarker in Multiple Sclerosis (CAVS-MS)” is an NIH-supported, 2-year, prospective, international, multicenter study conducted by the North American Imaging in MS Cooperative (NAIMS) to evaluate CVS as a diagnostic biomarker for immediate translation into clinical care. Study objectives include determining the concordance of CVS and McDonald Criteria to diagnose MS, the sensitivity of CVS to detect MS in those with typical presentations, and the specificity of CVS among those with atypical presentations. The study will recruit a total of 400 participants (200 with typical and 200 with atypical presentations) across 11 sites. T2*-weighted, high-isotropic-resolution, segmented echo-planar MRI will be acquired at baseline and 24 months on 3-tesla scanners, and FLAIR* images (combination of FLAIR and T2*) will be generated for evaluating CVS. Data will be processed on a cloud-based platform that contains clinical and CVS rating modules. Imaging quality control will be conducted by automated methods and neuroradiologist review. CVS will be determined by Select6* and Select3* lesion methods following published criteria at each site and by central readers, including neurologists and neuroradiologists. Automated CVS detection and algorithms for incorporation of CVS into McDonald Criteria will be tested. Diagnosis will be adjudicated by three neurologists who served on the 2017 International Panel on the Diagnosis of MS. The CAVS-MS study aims to definitively establish CVS as a diagnostic biomarker that can be applied broadly to individuals presenting for evaluation of the diagnosis of MS. |
Databáze: | OpenAIRE |
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