NCT04445584招募中不适用
7 Tesla MRI Evaluation of the Spine
Balgrist University Hospital2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- standard values (diameter in mm) of nerve roots/ganglia/neuroforamen in each segment
研究概览
简要总结
High-resolution MRI (7 Tesla) of the cervical spine is capable to provide good differentiation between nerve and surrounding tissues within foramen und allows to reliably quantify the diameter of nerve roots/ganglia. Secondly, detailed anatomy of vertebral artery and its relation to neural structures / foramina can be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed consent as documented by signature (Appendix Informed Consent Form)
- •>18 years old
- •Patients presenting chronic back pain (> 2 months) without recent trauma, previous MRI (1,5 or 3T) for clinicals indications or asymptomatic individuals (for depicting normal microanatomy)
排除标准
- •previous surgery
- •tumor patients
- •pregnancy or breast feeding
- •any MRI contra-indications
- •any MRI contra-indications
结局指标
主要结局
standard values (diameter in mm) of nerve roots/ganglia/neuroforamen in each segment
时间窗: 1 year
measure the diameter of the neuroforamen (in mm) and the diameter of each cervical nerve root/ganglion within the neuroforamen (in mm)
次要结局
- relation of vertebral artery to neural structures - assessment of contact between ganglion/spinal nerve and vertebral artery by assessing the presence of fat tissue between these structures.(1 year)
研究者
Reto Sutter, MD
Chief of radiology, MD
Balgrist University Hospital
研究点 (2)
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