This is a pilot and feasibility study assessing the role of quantitative multiparametric MRI and blood-based biomarkers for the measurement of liver function in patients receiving radiation therapy for liver cancer, including hepatocellular carcinoma (HCC), cholangiocarcinoma, or liver metastases regardless of primary histology, that are undergoing photon radiation either in the de-novo or re-irradiation setting. The goal of this study is to prospectively evaluate the feasibility of using quantitative multiparametric MRI to monitor liver function at baseline and following liver radiation therapy.
None
Age > 18
Patient has the psychological ability and general health needed to provide informed consent, completion of study requirements, and required follow-up
Patient provides study-specific informed consent prior to study entry
All primary histologies (Hepatocellular carcinoma or Cholangiocarcinoma) as well as hepatic metastases are eligible
Parallel
HepQuant DuO
Diagnostic testHepQuant DuO is a quantitative liver function test. It assesses cholate uptake, a liver specific function. Cholate is a naturally occurring substance that is cleared by the liver. Cholate uptake reflects the health of liver cells.
Multiparametric MRI Scans
Other interventionStandard of care
Feasibility of Quantitative MRI
Feasibility will be determined by assessing the proportion/percentage of participants who complete at least 2 quantitative multiparametric MRI scans following study enrollment. The proportion/percentage of patients will be summarized by study arm using basic descriptive statistics and a Clopper-Pearson 95% exact confidence interval will be determined.
Change in Disease Severity Index (DSI) score
Change in DSI scores from baseline will be evaluated using the HepQuant DuO test. The HepQuant DuO test measures the liver's ability to clear cholate from the blood using the Disease Severity Index (DSI). The DSI is a single score calculation that incorporates measures of both hepatocyte function and portal circulation and is calculated by indexing a patient's hepatic filtration rate (HFR) against maximum HFR and generates a liver DSI score ranging from 0 (no hepatic disease) to 50 (severe hepatic disease) such that increased DSI scores are correlated with worsening liver function and disease severity and progression. For purposes of this study change in DSI score from baseline will be summarized using basic descriptive statistics and will be examined using a Wilcoxon Sign rank test.
Predictive ability of LiverMultiScan
The ability of the LiverMultiScan to predict the risk of non-classic RILD will be evaluated. The pre-SBRT liver health assessment score will be calculated by measuring the Future Liver Remnant volume outside the 50% radiation isodose line weighted by the liver cT1 value. MRI images will be post-processed using LiverMultiScan, which provides a multiparametric quantitative map of a region of interest in the liver including characterization of the underlying liver fibroinflammation as reported by a corrected T1 (cT1) value, which will be measured and reported in milliseconds (ms). The likelihood of non-classic RILD based on the cT1 value will be assessed using multivariable logistic regression. Non-classic RILD will be defined as either worsening of Child-Pugh Score by \>=2 points (overall range: 5-15 points) at 6 months following SBRT or an elevated aminotransferase (ALT or AST) level \> 5 times the upper limit of normal or baseline value within 90 days of completion of SBRT.
Change in Total Liver Volume
Change in total liver volume from pre-SBRT treatment at baseline will be evaluated using Gd-EOB-DTPA enhanced MRI of the abdomen at the specified timeframes to assess the impact of radiotherapy. Mean changes in total liver volume (in mL or cm\^3) will be assessed using the MRI software image analysis and summarized by study arm and data will be analyzed using linear mixed-effects models. Increases in liver volume are correlated to more favorable outcomes.
Change in volume of non-irradiated and irradiated liver lobes
Change in volume of non-irradiated and irradiated liver lobes, from pre-SBRT treatment at baseline will be evaluated using Gd-EOB-DTPA enhanced MRI of the abdomen at the specified timeframes to assess the impact of radiotherapy. Mean changes in the volume of non-irradiated and irradiate lobes (in mL or cm\^3) will be assessed using the MRI software image analysis and summarized by study arm and data will be analyzed using linear mixed-effects models. Increases in liver lobe volume are correlated to more favorable outcomes.
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