A Multi-centric Study of the Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,051
- 试验地点
- 1
- 主要终点
- differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity)
研究概览
简要总结
This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.
详细描述
CLs and LCLs may be detected at 3 Tesla (T) MRI by using dedicated sequences. 3D Double inversion recovery (DIR), Phase-Sensitive Inversion Recovery (PSIR), Magnetization Prepared - RApid Gradient Echo (MPRAGE) and Magnetization Prepared - 2- RApid Gradient Echo (MP2RAGE) have all shown variable sensitivity to CLs and LCLs. The central vein sign (CVS, i.e. the detection of a central vessel in a focal lesion) has been recently proposed as a biomarker for distinguishing between MS and not and not MS. Both the presence of CL and CVs brings high sensitivity and specificity in distinguishing MS from not MS patients; whether their combination achieves higher sensitivity and specificity to MS diagnosis and differential diagnosis is to date not know. This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and MRI data of patients with MS or MS mimics (migraine, vasculitis, diabetes, neuromyelitis optica spectrum disorder)
- •MRI data must have been collected at 3T between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection) and DIR/PSIR/MP2RAGE (eventually also high spatial resolution MPRAGE) for cortical lesion detection
排除标准
- •Unavailability of institutional informed consent
- •Unclear diagnosis
- •Other neurological or psychiatric diseases.
结局指标
主要结局
differentiation between patients with MS and clinically isolated syndrome and patients without MS (specificity)
时间窗: at Baseline
differentiation between patients with MS and clinically isolated syndrome and patients without MS by analyzing the combination of the presence of CL/LCLs and CVs as compared to the sensitivity/specificity achieved by either CL/LCLs or CVs (sensitivity)
differentiation between patients with MS and clinically isolated syndrome and patients without MS ((specificity)
时间窗: at Baseline
differentiation between patients with MS and clinically isolated syndrome and patients without MS by analyzing the combination of the presence of CL/LCLs and CVs as compared to the sensitivity/specificity achieved by either CL/LCLs or CVs (sensitivity)
sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
时间窗: at Baseline
sensitivity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
时间窗: at Baseline
specificity of the combination of CLs/ LCLs compared to the one of the current diagnostic criteria for MS diagnosis
次要结局
未报告次要终点