NCT04441554招募中不适用
7 Tesla MRI Evaluation of the Spine
Reto Sutter, MD2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2020年3月4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
- differentiation of compressed nerves in neuroforamen (7T vs 3T)
研究概览
简要总结
High-resolution MRI (7 Tesla) of the spine is capable to differentiate osseous spurs from discus-material and better depict the compressed nerve in the neuroforamen compared to 3T MRI.
Provide the surgeon with a detailed high-resolution anatomical image before surgery and potential no need for CT (if the bony anatomy is of crucial importance).
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
结局指标
主要结局
differentiation of compressed nerves in neuroforamen (7T vs 3T)
时间窗: 2 years
次要结局
未报告次要终点
研究者
Reto Sutter, MD
chief of radiology
Balgrist University Hospital
研究点 (2)
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