Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Presence of ongoing inflammation (acute or chronic) in the SC
研究概览
简要总结
This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.
详细描述
An averaged magnetization inversion recovery acquisitions (AMIRA) sequence was proposed for SC MRI. This MR-sequence delivers excellent contrast between the SC gray and white matter as well as between the SC and cerebrospinal fluid (CSF) in clinically feasible-acquisition times. Moreover, the high quality and in-plane resolution of AMIRA images allows for segmentation of the SC gray and white matter with high accuracy and reproducibility. This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple sclerosis according to established international criteria
- •Steroid free period: > 4 weeks
- •Participation in the Swiss MS Cohort (SMSC) study
排除标准
- •. History of severe (other) neurological, internal or psychiatric disease with SC affection
- •MRI-related exclusion criteria (questionnaire):
- •Paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the SC)
- •Claustrophobia
- •Pregnancy, lactation
- •Known hypersensitivity to gadolinium-based contrast media
研究组 & 干预措施
Spinal Cord MRI
干预措施: SC MRI (Procedure)
Spinal Cord MRI
干预措施: patient questionnaire (Other)
结局指标
主要结局
Presence of ongoing inflammation (acute or chronic) in the SC
时间窗: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Presence of ongoing inflammation (acute or chronic) in the SC 3D MPRAGE and 3D fluid-attenuated inversion recovery images after intravenous gadolinium (Gd) contrast administration (0.1 mmol per kg body weight)
Number of SC lesions
时间窗: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Number of SC lesions using AMIRA compared to gold-standard conventional SC MRI sequences
Inter-observer agreement on SC lesion count
时间窗: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Inter-observer agreement with regard to lesion detection using AMIRA compared to gold-standard conventional SC MRI sequences.
次要结局
未报告次要终点