Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:6/2/2018
Start Date:January 2003
End Date:April 2019
Contact:Kyle Cuneo, MD
Email:kcuneo@umich.edu
Phone:734-845-3914

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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.

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.

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
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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