2020 年 17 巻 2 号 p. 81-85
The Institute for Integrated Radiation and Nuclear Science, Kyoto University has been working with Sumitomo Heavy Industries, Ltd. to develop a boron neutron capture therapy (BNCT) system using a cyclotron since 2007. After a joint non-clinical trial of boron drug with STELLA PHARMA CORPORATION, as a clinical trial of Sumitomo Heavy Industries, Ltd. and STELLA PHARMA CORPORATION, the world’s first accelerator-based BNCT phase I clinical trial for recurrent malignant glioma was started in 2012. Phase I clinical trial for head and neck cancer was also started in 2014. In 2016, we started a phase II clinical trial for recurrent malignant glioma jointly with the Southern TOHOKU BNCT Research Center. From the same year, a phase II clinical trial for head and neck cancer was started at the Southern TOHOKU BNCT Research Center. Based on this result, Sumitomo Heavy Industries, Ltd. obtained medical device approval for manufacturing and sales of accelerator based BNCT system NeuCure™ on March 11, 2020 for the treatment of locally unresectable recurrent or unresectable advanced head and neck cancer. STELLA PHARMA CORPORATION received approval on March 25, 2020, to manufacture and sell Steboronin®. This paper presents an outline and current status of a boron neutron capture therapy system using a cyclotron.