Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation

Completed

Conditions studied: Hepatic Irradiation

In brief

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.

Key facts

Study ID

NCT01519219

Run by

University of Michigan Rogel Cancer Center

People needed

208

Starts

2004-11-24

Expected to finish

2020-02-19

Last updated by the study team

2020-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Pregnant
• History of allergy or are sensitive to IC-Green, iodine or to radiographic media

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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