TY - JOUR
T1 - Central vein sign
T2 - A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial
AU - North American Imaging in MS Cooperative
AU - Ontaneda, D.
AU - Sati, P.
AU - Raza, P.
AU - Kilbane, M.
AU - Gombos, E.
AU - Alvarez, E.
AU - Azevedo, C.
AU - Calabresi, P.
AU - Cohen, J. A.
AU - Freeman, L.
AU - Henry, R. G.
AU - Longbrake, E. E.
AU - Mitra, N.
AU - Illenberger, N.
AU - Schindler, M.
AU - Moreno-Dominguez, D.
AU - Ramos, M.
AU - Mowry, E.
AU - Oh, J.
AU - Rodrigues, P.
AU - Chahin, S.
AU - Kaisey, M.
AU - Waubant, E.
AU - Cutter, G.
AU - Shinohara, R.
AU - Reich, D. S.
AU - Solomon, A.
AU - Sicotte, N. L.
N1 - Publisher Copyright:
© 2021 The Authors
PY - 2021/1
Y1 - 2021/1
N2 - 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.
AB - 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.
KW - Biomarker
KW - Central vein
KW - Demyelinating disease
KW - Diagnosis
KW - MRI
KW - Multiple sclerosis
KW - Susceptibility-weighted imaging
KW - T2-weighted imaging
UR - http://www.scopus.com/inward/record.url?scp=85115980253&partnerID=8YFLogxK
U2 - 10.1016/j.nicl.2021.102834
DO - 10.1016/j.nicl.2021.102834
M3 - Article
C2 - 34592690
AN - SCOPUS:85115980253
SN - 2213-1582
VL - 32
JO - NeuroImage: Clinical
JF - NeuroImage: Clinical
M1 - 102834
ER -