A Custom-Designed MR Coil for Spine Radiotherapy Treatment Planning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Optimize performance
研究概览
简要总结
The purpose of this study is to assess the image quality improvement provided by a custom MR spine coil in comparison with the FDA approved coil when used for radiotherapy treatment planning.
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
- 是
入选标准
- •Healthy Volunteers age 18 or older
排除标准
- •Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire
- •Volunteers with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
- •Female volunteers who are pregnant or nursing
- •Volunteers who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety
- •Volunteers who are under direct supervision of any investigators on the study will not be eligible to participate
结局指标
主要结局
Optimize performance
时间窗: Day of intervention
Optimize performance of custom-designed spine coil in RT configuration on participants. This objective focuses on the technology of the custom designed spine coil and does not require any statistical analysis.
Compare the signal-to-noise ratio of a custom spine coil with the existing FDA approved posterior coil array used for spine imaging
时间窗: Day of intervention
To quantify image quality obtained from the custom spine coil and the existing coil, SNR will be calculated (see Section 4.1 for details) for both coils. If, for a volunteer, the SNR from the custom coil is larger than 105% of that from the existing coil (we insist a 5% improvement margin due to anticipated uncertainty and variability), then we will classify this sample point as a "success". We will combine the 15 volunteers from the three cohorts (cervical-spine, thoracic-spine and lumbar-spine) and impose the following decision rule: If at least 12 out of the total 15 volunteers are success, then we declare the custom designed spine coil promising and worthy of further investigation.
次要结局
未报告次要终点