Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial.

Central vein sign: A diagnostic biomarker in multiple sclerosis (CAVS-MS) study protocol for a prospective multicenter trial.
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DOI:
10.1016/j.nicl.2021.102834
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发表时间:
2021
期刊:
NeuroImage. Clinical
影响因子:
--
通讯作者:
North American Imaging in MS Cooperative
North American Imaging in MS Cooperative
中科院分区:
其他
文献类型:
--
作者:
Ontaneda D;Sati P;Raza P;Kilbane M;Gombos E;Alvarez E;Azevedo C;Calabresi P;Cohen JA;Freeman L;Henry RG;Longbrake EE;Mitra N;Illenberger N;Schindler M;Moreno-Dominguez D;Ramos M;Mowry E;Oh J;Rodrigues P;Chahin S;Kaisey M;Waubant E;Cutter G;Shinohara R;Reich DS;Solomon A;Sicotte NL;North American Imaging in MS Cooperative

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大约五分之一的多发性硬化症患者没有患病。中央静脉是多发性硬化症与其他白质病变的鉴别标志。中心静脉征象尚未在多中心前瞻性研究中得到评价。CAVS-MS是一项验证中心静脉的前瞻性多中心研究。CAVS-MS将使用et2 *加权、高各向同性分辨率、分段回波平面MRI。目前基于mri的多发性硬化(MS)诊断标准的特异性和实施是不完善的。大约五分之一被诊断为多发性硬化症的人最终被确定没有患病,过度依赖MRI检查结果是多发性硬化症误诊的主要原因。中心静脉征象(CVS)是一种建议的多发性硬化症病变的MRI生物标志物,已在许多横断面研究中得到广泛研究,并可能增加多发性硬化症的诊断特异性。CVS具有理想的分析、测量和可扩展性。“中央静脉征象:多发性硬化症的一种诊断性生物标志物(CAVS-MS)”是美国国立卫生研究院支持的一项为期2年的前瞻性国际多中心研究,由北美MS成像合作组织(NAIMS)开展,旨在评估CVS作为一种诊断性生物标志物可立即转化为临床护理。研究目的包括确定CVS与麦当劳标准诊断MS的一致性,CVS在典型表现中检测MS的敏感性,以及CVS在非典型表现中检测MS的特异性。该研究将在11个站点招募总共400名参与者(200名典型和200名非典型演示)。将在基线和24个月时在3-tesla扫描仪上获得T2*加权、高各向同性分辨率、分段回声平面MRI,并生成FLAIR*图像(FLAIR和T2*的组合)用于评估CVS。数据将在包含临床和CVS评级模块的云平台上处理。成像质量控制将通过自动化方法和神经放射学家审查进行。CVS将通过Select6*和Select3*病变方法确定,这些方法遵循每个部位公布的标准,并由中枢读者(包括神经科医生和神经放射科医生)确定。将测试自动CVS检测和将CVS纳入麦当劳标准的算法。诊断将由2017年国际多发性硬化症诊断小组的三名神经学家进行裁决。CAVS-MS研究旨在明确建立CVS作为一种诊断生物标志物,可以广泛应用于多发性硬化症的诊断评估。
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.
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