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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Assessment Of Liver Function in Patients Undergoing Hepatic Irradiation|
- Baseline IC-GREEN elimination [ Time Frame: 1 day ] [ Designated as safety issue: No ]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.
- Change in IC-green elimination after radiation therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519219
|Contact: Mary Feng, MD||(734) firstname.lastname@example.org|
|Contact: Jody Sharp||(734) email@example.com|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109-5010|
|Contact: Cancer AnswerLine 800-865-1125 firstname.lastname@example.org|
|Principal Investigator:||Mary Feng, MD||University of Michigan Cancer Center|