Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation

NCT ID: NCT01519219

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 208 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-11-24
• Study Completion Date: 2020-02-19

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.

Conditions

Hepatic Irradiation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatic Irradiation

Hepatic Irradiation

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore Lawrence, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00041352

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2003.081

Identifier Type: -

Identifier Source: org_study_id