A Pilot Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Measure of Liver Function Before, During and After Radiation
研究概览
简要总结
Researchers at the the University of Michigan are conducting a research project to assess how a course of radiation therapy changes the way blood flows through the liver. To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy. MRI's will be done on 4 or 5 occasions. On each occasion, you will be injected with a fluid called gadolinium (a contrast agent) before getting an MRI. This contrast agent makes it easier for the Researchers to see your organs in the scans, and causes any abnormal areas to become very bright on the MRI. This agent will be injected into a vein in your arm or leg. Each MRI scan will last approximately 45 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients must be ≥18 years of age.
- •The patient's planned cancer management is radiation to the liver with or without chemotherapy.
- •Patients must have a performance status of 0-2 and a life expectancy of at least 3 months.
- •Patients should have no contraindications to having a contrast enhanced MRI scan.
排除标准
- •Women who are pregnant or breastfeeding are excluded.
- •Prisoners are excluded
结局指标
主要结局
Measure of Liver Function Before, During and After Radiation
时间窗: 2-3 months for treatment; indefinite for follow-up
The primary objective of this research is to assess how a course of radiation therapy changes the way blood flows through the liver. Researchers want to use the information collected from this research for future research, to see if this change in blood flow indicates that an individual patient is at higher risk for complications from the radiation therapy, specifically Radiation-Induced Liver Disease (RILD). To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy.
次要结局
- Measure of Liver Perfusion(Follow-up - Approximately 7 Years)
- Association Between Liver Perfusion and Changes in Tumor and Clinical Outcomes(Follow-up - Approximately 7 years)