Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Baseline IC-GREEN elimination
研究概览
简要总结
The goal of the trial is to assess the effect of radiation treatment on liver function as determined by indocyanine green extraction. The long term goal is to determine if individual assessment of liver function using the IC-Green method, either alone or in combination with other factors, will provide Radiation Induced Liver Disease (RILD) risk-estimates that are superior to the probabilistic method currently in use.
详细描述
Following intravenous injection, IC-GREEN is rapidly bound to plasma protein, of which albumin is the principle carrier (95%). IC-GREEN is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile. It undergoes no significant extrahepatic or enterohepatic circulation. Simultaneous arterial and venous blood estimations have shown negligible renal, peripheral, lung or cerebro-spinal uptake of the dye. Therefore, the serum clearance rate (determined from serial serum concentration measurements at various times after intravenous injection) can serve as a useful index of liver function.
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
- •18 or older, all gender, ethnicities and races
- •Life expectancy of at least 12 weeks
- •Zubrod performance status ≤ 2
- •Baseline clinical assessments of liver function by complete history and physical examination
- •Laboratory tests to be done within 6 weeks prior to start of radiation: CBC and platelets, liver function tests including SGOT, SGPT, Alkaline Phosphatase, and bilirubin, albumin, BUN, creatinine, PT/PTT, INR
排除标准
- •History of allergy or are sensitive to IC-Green, iodine or to radiographic media
结局指标
主要结局
Baseline IC-GREEN elimination
时间窗: 1 day
Most subjects will have five IC-GREEN assessments. Graphical displays will be used to choose the form of a time-dependent model of IC-GREEN elimination. A mixed, possibly nonlinear model, with patient as random effect, will be fit to the data by the maximum likelihood principle. Profile confidence intervals for the parameters will be determined.
次要结局
- Change in IC-green elimination after radiation therapy(6 months)