Reproducibility of Brain Volume and Lesion Measurements in Multiple Sclerosis: a Scan-Rescan Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions
研究概览
简要总结
The primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants with MS. The secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each MS PATHS center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and l local participant privacy regulations.
- •Diagnosis of relapse-onset MS (relapsing-remitting or secondary progressive).
- •First MS symptom within the past 1 to 30 years.
排除标准
- •Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit
- •Steroid treatment or suspected MS relapse within 6 weeks prior to Visit
- •Note: Other protocol specified inclusion and exclusion criteria may apply.
结局指标
主要结局
Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions
时间窗: Baseline up to Day 7
Intrascanner Reproducibility of Brain Volume
时间窗: Baseline up to Day 7
Intrascanner Reproducibility of Lesions
时间窗: Baseline up to Day 7
Interscanner Reproducibility of Brain Volume
时间窗: Baseline up to Day 7
Sensitivity and Specificity for Lesion Detection
时间窗: Baseline up to Day 7
Interscanner Reproducibility of Lesions
时间窗: Baseline up to Day 7
Overall Reproducibility of Brain Volume
时间窗: Baseline up to Day 7
Overall Reproducibility of Lesions
时间窗: Baseline up to Day 7
Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions
时间窗: Baseline up to Day 7
次要结局
- Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners(Baseline up to Day 7)