Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial
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 cent...
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| Format: | Article |
| Language: | English |
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Elsevier
2021-01-01
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| Series: | NeuroImage: Clinical |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213158221002783 |
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| author | D. Ontaneda P. Sati P. Raza M. Kilbane E. Gombos E. Alvarez C. Azevedo P. Calabresi J.A. Cohen L. Freeman R.G. Henry E.E. Longbrake N. Mitra N. Illenberger M. Schindler D. Moreno-Dominguez M. Ramos E. Mowry J. Oh P. Rodrigues S. Chahin M. Kaisey E. Waubant G. Cutter R. Shinohara D.S. Reich A. Solomon N.L. Sicotte |
| author_facet | D. Ontaneda P. Sati P. Raza M. Kilbane E. Gombos E. Alvarez C. Azevedo P. Calabresi J.A. Cohen L. Freeman R.G. Henry E.E. Longbrake N. Mitra N. Illenberger M. Schindler D. Moreno-Dominguez M. Ramos E. Mowry J. Oh P. Rodrigues S. Chahin M. Kaisey E. Waubant G. Cutter R. Shinohara D.S. Reich A. Solomon N.L. Sicotte |
| author_sort | D. Ontaneda |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T23:24:22Z |
| format | Article |
| id | doaj.art-005ce31efb5d4a1abcacaa29012f4d5e |
| institution | Directory Open Access Journal |
| issn | 2213-1582 |
| language | English |
| last_indexed | 2024-12-14T23:24:22Z |
| publishDate | 2021-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | NeuroImage: Clinical |
| spelling | doaj.art-005ce31efb5d4a1abcacaa29012f4d5e2022-12-21T22:43:50ZengElsevierNeuroImage: Clinical2213-15822021-01-0132102834Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trialD. Ontaneda0P. Sati1P. Raza2M. Kilbane3E. Gombos4E. Alvarez5C. Azevedo6P. Calabresi7J.A. Cohen8L. Freeman9R.G. Henry10E.E. Longbrake11N. Mitra12N. Illenberger13M. Schindler14D. Moreno-Dominguez15M. Ramos16E. Mowry17J. Oh18P. Rodrigues19S. Chahin20M. Kaisey21E. Waubant22G. Cutter23R. Shinohara24D.S. Reich25A. Solomon26N.L. Sicotte27Cleveland Clinic Foundation, Cleveland, OH, United States; Corresponding author at: 9500 Euclid Avenue, Cleveland, OH 44195, United States.Cedars Sinai, Los Angeles, CA, United States; NINDS, NIH, Bethesda, MD, United StatesCleveland Clinic Foundation, Cleveland, OH, United StatesCleveland Clinic Foundation, Cleveland, OH, United StatesCedars Sinai, Los Angeles, CA, United StatesNeurology, U of Colorado, Denver, CO, United StatesUSC, Los Angeles, CA, United StatesNeurology, Johns Hopkins, Baltimore, MD, United StatesCleveland Clinic Foundation, Cleveland, OH, United StatesDell Medical School, The University of Texas at Austin, Austin, TX, United StatesUniversity of California San Francisco, San Francisco, CA, United StatesYale University, North Haven, CT, United StatesUniversity of Pennsylvania, Philadelphia, PA, United StatesUniversity of Pennsylvania, Philadelphia, PA, United StatesUniversity of Pennsylvania, Philadelphia, PA, United StatesQMENTA Inc, Boston, MA, United StatesQMENTA Inc, Boston, MA, United StatesNeurology, Johns Hopkins, Baltimore, MD, United StatesUniversity of Toronto, Toronto, ON, CanadaQMENTA Inc, Boston, MA, United StatesWashington University, St. Louis, MO, United StatesCedars Sinai, Los Angeles, CA, United StatesUniversity of California San Francisco, San Francisco, CA, United StatesUAB School of Public Health, Birmingham, AL, United StatesUniversity of Pennsylvania, Philadelphia, PA, United StatesNINDS, NIH, Bethesda, MD, United StatesThe University of Vermont, Burlington, VT, United StatesCedars Sinai, Los Angeles, CA, United StatesThe 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.http://www.sciencedirect.com/science/article/pii/S2213158221002783Multiple sclerosisMRIBiomarkerDiagnosisCentral veinDemyelinating disease |
| spellingShingle | D. Ontaneda P. Sati P. Raza M. Kilbane E. Gombos E. Alvarez C. Azevedo P. Calabresi J.A. Cohen L. Freeman R.G. Henry E.E. Longbrake N. Mitra N. Illenberger M. Schindler D. Moreno-Dominguez M. Ramos E. Mowry J. Oh P. Rodrigues S. Chahin M. Kaisey E. Waubant G. Cutter R. Shinohara D.S. Reich A. Solomon N.L. Sicotte Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial NeuroImage: Clinical Multiple sclerosis MRI Biomarker Diagnosis Central vein Demyelinating disease |
| title | Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial |
| title_full | Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial |
| title_fullStr | Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial |
| title_full_unstemmed | Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial |
| title_short | Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial |
| title_sort | central vein sign a diagnostic biomarker in multiple sclerosis cavs ms study protocol for a prospective multicenter trial |
| topic | Multiple sclerosis MRI Biomarker Diagnosis Central vein Demyelinating disease |
| url | http://www.sciencedirect.com/science/article/pii/S2213158221002783 |
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