Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation (IC-Green)

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Irradiation
• Intervention / Treatment: Radiation: Hepatic Irradiation

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 Type: Observational
• Enrollment (Actual): 208

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5010
      • University of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who take part in this study are required to be scheduled for hepatic irradiation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hepatic Irradiation	Radiation: Hepatic Irradiation; Patients who take part in this study are required to be scheduled for hepatic irradiation. For the purposes of this research, they will undergo IC-GREEN testing within 2 weeks prior to the start of radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline IC-GREEN elimination	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IC-green elimination after radiation therapy	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.	6 months

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Theodore Lawrence, MD, PhD, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2004
• Primary Completion (Actual): September 4, 2019
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: September 23, 2011
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: IC-GREEN; hepatic irradiation
• Other Study ID Numbers: UMCC 2003.081; HUM00041352 (Other Identifier: University of Michigan Medical IRB)