A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning
研究概览
简要总结
The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Difference in Functional Reserve of Liver Between Theragnostic SBRT Planning and Standard SBRT Planning
时间窗: Day -1 of Radiation Treatment
The functional reserve of the liver for both standard SBRT planning and theragnostic SBRT planning will be calculated for each patient regardless of which plan was ultimately chosen. Function reserve of the liver = (number of counts outside 15 Gy isodose line / total number of counts within the liver) \* global liver function; where global liver function is the rate of liver uptake (%/min) between 150 to 300 seconds normalized to body surface area (m\^2) using the Du Bois method. The difference in functional reserve between the theragnostic plan and the standard plan was calculated for each patient.
次要结局
- Time Until Salvage Treatment(Up to 15 months)
- Overall Survival(Up to 3 years)
- Percentage of Participants for Whom Theragnostically Planned Radiation is Chosen for the Radiation Treatment Plan(Day -1 of Radiation Treatment)
- Progression Free Survival(Up to 15 months)
- Change in MELD Score(Up to 1 year)
- Duration of Local Control(Up to 15 months)
- Time to Transplant(Up to 15 months)
- Time to Distant Liver Failure(Up to 15 months)
- Number of Patients With Treatment-Related Adverse Events Grade 3 or Above(Every 15 days for approximately 6 months)
研究者
Ryan Rhome,
Assistant Professor- Department of Radiation Oncology
Indiana University