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BTG to initiate TARGET study of microsphere therapy for HCC
BTG Plc announced plans to initiate the TARGET study to evaluate the use of TheraSphere therapy for patients with hepatocellular carcinoma, according to a news release.
The TARGET study, which stands for TheraSphere Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment, will evaluate normal tissue and tumor absorbed dose in patients with HCC in interventional oncology to create a more personalized approach to radioembolisation therapy for this patient population.
The primary endpoint of the study will determine the correlation between the normal tissue absorbed dose, based on 99mTc-MAA, and hyperbilirubinemia grade 3 or greater, for patients administered TheraSphere (BTG Plc). Secondary endpoints in the TARGET study include tumor absorbed dose, incidence of serious adverse events, select dose related adverse events, overall survival, among others, according to the release.
“The TARGET retrospective study will collect clinical data with the goal of outlining a two-compartment dosimetry model based on 99mTc-MAA dosimetry and customized software manufactured by Mirada Medical,” Marnix Lam, professor of nuclear medicine at UMC Utrecht, the Netherlands, said in the release. “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 tumor and normal liver, physicians will have the opportunity to better personalize 90Y radioembolisation therapy.”
Initiation of the study will most likely begin in July 2016, following approval by the Institutional Review Board and Ethics Committee in both the U.S. and select countries in Europe and Asia, according to the release.
Disclosure: Healio.com/Hepatology was unable to confirm relevant financial disclosures of Lam.