Explorative Technical Feasibility Testing of 7-Tesla Magnetic Resonance Imaging of the Musculoskeletal System and of the Head
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 780
- 试验地点
- 2
- 主要终点
- Qualitative image quality of 7 T MRI
研究概览
简要总结
The goal of the current project is to explore and develop the technical feasibility of non-invasive imaging of the human musculoskeletal system and head with the first 7T MR scanner with a CE mark to identify areas where the higher field promises significant benefits in qualitative image quality. For a subset of the planned exams, state-of-the art 7T or 3T images will be used as standard of reference to comparatively gauge the qualitative image quality of the investigational 7T images.
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
- 是
入选标准
- •Consent to undergo a 7T (and, if appropriate a comparative 3T) MRI exam.
- •For some of the consistent small series: presence of a specific condition of the musculoskeletal system or of the head. This can include traumatic or degenerative changes, e.g., of tendons, cartilage, muscle, peripheral nerves, ligaments, and bones, or in the brain, as well as focal lesions, e.g., tumors.
排除标准
- •Contraindications to undergo a MRI examination at a field strength of 7 Tesla or at 3 Tesla.
- •Irregular anatomy and/or tissue properties
- •Inability to consent - for any reason.
- •Body mass above 200 kg.
- •Body mass below 30 kg.
- •Women: pregnancy.
- •Age below
- •Known or suspected non-compliance, drug or alcohol abuse.
- •Inability to follow the procedures of the study.
结局指标
主要结局
Qualitative image quality of 7 T MRI
时间窗: through study completion, an average of 1 year
Current-day feasibility of various types of MR examinations of the human musculoskeletal system. The primary outcomes of small consistent series of the study are visual gradings and qualitative measures of image quality. Image quality is rated by independent readers using Likert scales.
次要结局
未报告次要终点
研究者
Reto Sutter, MD
Prof. Dr. med. Reto Sutter
Balgrist University Hospital