Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation

Completed

• Conditions: Hepatic Irradiation
• Interventions: Radiation: Hepatic Irradiation

• Registration Number: NCT01519219
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2004-11-24
• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Primary Completion: 2019-09-04
• Study Completion: 2020-02-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatic Irradiation	Hepatic Irradiation	-

Primary Outcome Measures

Name	Time	Method
Baseline IC-GREEN elimination	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.

Secondary Outcome Measures

Name	Time	Method
Change in IC-green elimination after radiation therapy	6 months	Using model parameters, a cumulative distribution function for IC-GREEN elimination at each time point will be determined from the patients who do not contract RILD. This will result in a smooth estimate of the IC-GREEN assay results, from which lower normal bounds (at, for instance, the fifth percentile) can be established.

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States