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.

目前基于 MRI 的多发性硬化症 (MS) 诊断标准的特异性和实施并不完善。大约五分之一的被诊断患有多发性硬化症的人最终被确定没有患有这种疾病，过度依赖 MRI 结果是多发性硬化症误诊的主要原因。中央静脉征 (CVS) 是一种拟议的多发性硬化症病变 MRI 生物标志物，已在众多横断面研究中得到广泛研究，可能会提高多发性硬化症的诊断特异性。 CVS 具有理想的分析、测量和可扩展性特性。 “中央静脉征：多发性硬化症的诊断生物标志物 (CAVS-MS)”是一项由 NIH 支持的、为期 2 年的前瞻性国际多中心研究，由北美 MS 影像合作组织 (NAIMS) 进行，旨在评估 CVS 作为诊断生物标志物可立即转化为临床护理。研究目标包括确定 CVS 和 McDonald 标准诊断 MS 的一致性、CVS 在典型表现患者中检测 MS 的敏感性，以及 CVS 在非典型表现患者中的特异性。该研究将在 11 个地点招募总共 400 名参与者（200 名典型表现和 200 名非典型表现）。将在基线和 24 个月时在 3 特斯拉扫描仪上采集 T2* 加权、高各向同性分辨率、分段回波平面 MRI，并将生成 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进行处理。成像质量控制将通过自动化方法和神经放射科医生审查进行。 CVS 将由 Select6* 和 Select3* 病变方法根据每个站点公布的标准并由中央读者（包括神经科医生和神经放射科医生）确定。 将测试自动 CVS 检测以及将 CVS 纳入 McDonald Criteria 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科医生做出裁决。 CAVS-MS 研究旨在明确将 CVS 确立为一种诊断生物标志物，可广泛应用于评估 MS 诊断的个体。