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Frequently Asked Questions
Oncosil is currently unapproved in any jurisdiction. This product is currently undertaking clinical trials in approved and selected trial sites that have undergone an ethics process. The following warnings and precautions is provided for all participating trial hospitals.
OncoSil™, is comprised of OncoSil Phosphorous-32 Microparticles and OncoSil Diluent. OncoSil™ is an active implantable (radiological) medical device intended for use in brachytherapy, where cancer is treated by the insertion of radioactive implants directly into the cancerous tissue.
OncoSil™ is a brachytherapy device that implants a pre-determined dose of beta radiation emitting isotope directly into cancerous tissue. OncoSil™ is implanted into pancreatic tumours via Endoscopic Ultrasound (EUS) guidance.
The beta particles emitted by OncoSil™ travel a short distance in tissue causing direct damage to cancer cell DNA, which renders them incapable of further cell division and proliferation. Through this mechanism, OncoSil™ is able to stop cancer cells from multiplying and ultimately shrink tumour masses when the cells eventually die.
All medical treatments have known or unforeseeable side effects and risks. In the previous clinical studies, the following adverse events were considered to have a probable or definite causal relationship with OncoSil™:
Abdominal pain and discomfort
Abnormal liver function and tests
Although not experienced by any of the patients previously dosed with OncoSil™, there are potential sub‐acute/late effects of radiation, such as gastrointestinal haemorrhages, bowel ulceration, enteritis, perforations, fistula and stricture that could occur.
In addition to the risks listed in the above section, there may be further risks to the patients, the nature of which are unknown.
Brachytherapy targets tumours more precisely and delivers higher tumouricidal doses of ionising radiation, while reducing the radiation exposure in the surrounding healthy tissues than external beam radiation therapy. Brachytherapy may cause fewer side effects than external beam radiation, the overall treatment time is usually shorter with brachytherapy¹ and the procedure can be conducted on an out-patient basis.
¹ Mayo Clinic, “Tests and Procedures, Brachytherapy, Definition”, http://www.mayoclinic.org/tests-procedures/brachytherapy/basics/definition/prc-20021316