An observational study in Hepatic Irradiation, sponsored by University of Michigan Rogel Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by University of Michigan Rogel Cancer Center · Observational
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.
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.
University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who take part in this study are required to be scheduled for hepatic irradiation.
Exclusion Criteria:
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
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.
Time frame: 1 day
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.
Time frame: 6 months
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center