Comprehensive Assessment of Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) Measures: Reproducibility and Repeatability in Pelvic Imaging on MR-Linac With Healthy Volunteers. (PILLAR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Assess the repeatability coefficient (RC) (percentage)
研究概览
简要总结
This study evaluates the reliability of functional MRI measurements in pelvic disease through quantifying repeatability and reproducibility, using healthy volunteers. The aim is to provide insights into the consistency of results across sessions and observers, informing the trustworthiness of functional MRI in assessing pelvic disease and particularly rectal cancers and guiding protocol optimization.
详细描述
Volunteers will be required to complete a questionnaire to ensure their eligibility and safety for undergoing an MRI. This questionnaire, along with safety information, will be reviewed before each MR session.
Subsequently, volunteers will undergo three MRI sessions, ideally two on the same day, with the last session scheduled 10 to 17 days apart from the previous ones. Each session is expected to last approximately 60 minutes (several sequences), and no contrast agent will be injected at any point.
On the first day, volunteers will have an MRI on the 1.5 Tesla MR-Linac Unity (Elekta device) and an MRI on a standard 1.5 Tesla MRI (Siemens). Between days 10 to 17, they will exclusively undergo an MR-Linac session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Volunteer
- •Ability to undergo an MRI
排除标准
- •Contraindication to undergoing an MRI (see safety questionnaire)
- •Previous pelvic irradiation
- •Pelvic pathology
结局指标
主要结局
Assess the repeatability coefficient (RC) (percentage)
时间窗: Day 1 and Day 10-17
Quantitative assessment of the Repeatability Coefficient for functional MRI sequences in rectal tissue, expressed as a percentage.
Assess the reproducibility coefficient (RDC) (percentage)
时间窗: Day 1 and Day 10-17
Comparative analysis of Repeatability Coefficient values obtained from distinct MRI devices, providing insights into device-specific variations.
次要结局
- Percentage of variation between the different calculation Methods for Repeatability Coefficient.(Day 1 and Day 10-17)
- Percentage of variation across various pelvic organs for Repeatability Coefficient.(Day 1 and Day 10-17)