Device Dossier

OncoSil™ System - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant

Device Dossier for OncoSil™ System - Radionuclide source, therapeutic, brachytherapy, manual, permanent implant (Radionuclide source, therapeutic,…

Intended purpose

The OncoSil™ System is intended to induce prolonged local tumour control and tumour size reduction in patients with locally advanced unresectable pancreatic cancer, in addition to gemcitabine-based chemotherapy, by implantation of radioactive Phosphorous-32 Microparticles into pancreatic tumours under endoscopic ultrasound guidance.

Functional description

OncoSil™, is comprised of Phosphorous-32 Microparticles and OncoSil Diluent. The Microparticles contain Phosphorous-32, a pure beta-emitter radioisotope with a physical half-life of 14.27 days. The maximum energy of the emitted beta particles is 1.711 MeV. The average energy of the emitted beta particles is 0.6950 MeV. The maximum range of emissions in tissue is 8.2 mm. The average range of emissions in tissue is 2.76 mm. In therapeutic use 98% of the radiation is delivered within 81 days

TGA Public Summary