The study will evaluate two-compartment dosimetry (normal tissue and tumour absorbed dose) in hepatocellular carcinoma patients in interventional oncology in an effort towards a more personalised approach to Y-90 radioembolization for liver cancer patients.
Peter Pattison, BTG general manager Interventional Oncology, commented “BTG investment in TARGET demonstrates our goal to further tailor TheraSphere therapy to individual patient liver, tumour and disease characteristics. TARGET will complement other studies, and will be undertaken in collaboration with leading clinical and industry partners in this field, with the ultimate goal of improving patient outcomes in hepatocellular carcinoma.”
The primary endpoint of the study will determine the correlation between the normal tissue absorbed dose, based on 99mTc-MAA, and ≥Grade 3 hyperbilirubinemia for patients administered TheraSphere. Secondary endpoints in the TARGET study include: tumour absorbed dose, incidence of serious adverse events, select dose-related adverse events, clinical laboratory assessment, objective tumour response and overall survival.
“The current one-compartment dosimetry method for TheraSphere incorporates a target absorbed dose to the entire liver and adjusts for liver mass, however a more individualised approach is needed to optimise dosimetry.” said Marnix Lam, Nuclear Medicine, UMC Utrecht, Netherlands. “The TARGET retrospective study will collect clinical data with the goal of outlining a two-compartment dosimetry model based on 99mTc-MAA dosimetry and customised software manufactured by Mirada Medical. The objective of the study is to provide treating physicians with clinical data that will allow a more tailored dosimetry approach for treating patients. By taking into account the absorbed dose to tumour and normal liver, physicians will have the opportunity to better personalise Y-90 radioembolization therapy.”
BTG plans to initiate the study in July 2016 following IRB and EC approval in the United States and select countries in Europe and Asia.