LONDON, April 2, 2016 /PRNewswire/ --
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.
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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.
About TheraSphere®
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
http://www.therasphere.com.