BTG has announced plans to begin the TheraSphere Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment (TARGET) study.
The study will evaluate two-compartment dosimetry, including normal tissue and tumour absorbed dose, in hepatocellular carcinoma patients in interventional oncology.
The trial aims to have a more personalised approach than before to 90Y radioembolisation therapy for liver cancer patients.
BTG expects to begin the study in July this year following approval of Institutional Review Board (IRB) IRB and European Commission (EC) in the US and select countries in Europe and Asia.
BTG interventional oncology general manager Peter Pattison said: "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 HCC."
TARGET’s primary endpoint expects to identify the correlation between the normal tissue absorbed dose, based on 99mTc-MAA, and =Grade 3 hyperbilirubinemia for patients with TheraSphere, while the secondary endpoints in the trial cover tumour absorbed dose, incidence of serious adverse events, select dose related adverse events, clinical laboratory assessment, objective tumour response and overall survival.
UMC Utrecht Netherlands nuclear medicine professor Marnix Lam said: "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.
"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 90Y radioembolisation therapy."