April 02, 2016
BTG to initiate multi-centre TARGET study
London, UK, 02 April 2016
BTG to initiate multi-centre TARGET study evaluating dosimetry for 90Y radioembolisation therapy in patients with hepatocellular carcinoma
BTG plc (LSE: BTG), a global specialist healthcare company, today announced plans to initiate the TheraSphere® Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment (TARGET). 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 90Y radioembolisation therapy 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 compliment 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.”
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 Professor 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 90Y radioembolisation 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.
About BTG Interventional Medicine
BTG Interventional Medicine is part of BTG plc, a growing international specialist healthcare company. As medicine moves from major surgery to minor procedure, from the systemic to the local, no company endeavours to do more than BTG Interventional Medicine to help doctors in their quest to see more, reach further and treat smarter. Our growing portfolio of Interventional Medicine products is designed to advance the treatment of liver tumours, advanced emphysema, severe blood clots, and varicose veins. To learn more about BTG Interventional Medicine, please visit: www.btg-im.com.
TheraSphere® 90Y glass microspheres are specifically engineered to carry far greater power than any other 90Y liver-directed cancer therapy, delivering high doses of radiation to liver tumours while sparing normal tissue. The result is a powerful, targeted and well-tolerated therapy that may lead to patients becoming eligible for curative therapies.
In the EU, Singapore, South Korea and Canada, TheraSphere® is approved for the treatment of hepatic neoplasia. In the US, TheraSphere® is approved under a Humanitarian Device Exemption (HDE) for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of this device for this use has not been demonstrated. For full instructions for use and important safety information, please visit www.therasphere.com.
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