Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation (IC-Green)
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
- 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
Exclusion criteria
- Pregnant
- History of allergy or are sensitive to IC-Green, iodine or to radiographic media
Trial design
208 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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