University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-5010, United States
Completed
NCT Number: NCT01519219
Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Hepatic Irradiation
RadiationPatients 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
Primary outcomes
-
Baseline IC-GREEN elimination
Time frame: 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 outcomes
-
Change in IC-green elimination after radiation therapy
Time frame: 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.
Sponsors and collaborators
Lead sponsor
University of Michigan Rogel Cancer Center
Other
Registry information
Acronym: IC-Green
Important dates
- Study start
- 2004
- Primary completion
- 2019
- Study completion
- 2020
- First posted
- Jan 26, 2012
- Registry last updated
- May 20, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.