Social Issues addressed by Sumitomo —Compass for the Future—

Sumitomo Heavy Industries × Advanced Medicine

Epoch-making medical device offers hope to cancer patients—World’s first BNCT system with medical device approval

 Advanced medicine
Thanks to the progress of technology and the advent of ever-more sophisticated medical equipment, it has become possible to cure diseases and treat injuries that once defied the best efforts of medical science, thereby not only saving more lives but also achieving early detection of diseases and improved diagnostic accuracy. Medical care that supports patients’ quality of life (QOL) is also advancing. For example, robot-assisted surgery and PET/CT scans that can diagnose cancer anywhere in the body are making dramatic leaps forward. Such progress in medicine is largely due to the efforts of not only universities and other research institutions but also of companies to develop cutting-edge technologies. Sumitomo Heavy Industries is contributing to the advancement of medical care through its development of an innovative medical system that enables the treatment of cancer whose treatment with other means such as surgery is impracticable.

Cancer remains a major scourge of humankind. In particular, tackling cancer that is difficult to treat with conventional methods remains an uphill struggle. However, certain state-of-the-art technologies are showing promise in the treatment of hitherto intractable cancers, and various initiatives are now underway.

Radiation therapy, chemotherapy, and surgery are the three major types of cancer treatment. Cancer that has locally recurred after radiation therapy is difficult to treat again with radiation therapy because of the risk that normal cells in the vicinity of the cancerous cells may be adversely affected. In these circumstances, an epoch-making method of radiation therapy that involves irradiation only once and is applicable to parts of the body previously subjected to radiation therapy has become available. Sumitomo Heavy Industries (SHI) manufactures and sells the world’s first BNCT (Boron Neutron Capture Therapy) system approved as a medical device.

NeuCure is the world’s first medical device approved for BNCT.

With BNCT, a boron agent, which is easily accepted by cancer cells, is administered to the patient and a neutron beam is irradiated from outside. This causes the boron to react with neutrons and destroy cancer cells. BNCT differs markedly from conventional radiation therapy in two aspects: use of neutrons and use in combination with a medical agent.

Fission inside the body. The boron captures neutrons and this reaction releases α particles (helium nuclei) and lithium particles (Li recoil nuclei). These two types of particles selectively destroy cancer cells.

The idea of using neutrons for cancer treatment has been around since the 1930s when the existence of neutrons was proven. In Japan, clinical research on neutron capture therapy began in 1968, which involved irradiating neutrons to cancer cells that have accepted certain elements. The boron compound mentioned above was subsequently developed and research has continued. However, because of the need for a nuclear reactor to generate neutrons, there was a high practical barrier to widespread use of BNCT in medical facilities.

SHI overcame this barrier by developing a cyclotron, which is a compact particle accelerator, for BNCT.

Cyclotron accelerator of NeuCure. High-energy protons are extracted by accelerating negative hydrogen ions to produce a proton beam.

SHI began developing cyclotrons in the early 1970s. They were initially developed for use in physics research at universities and research institutes, but they subsequently showed growing promise for medical applications. From the 1980s onward, SHI developed and supplied cyclotrons for PET (positron emission tomography) for cancer diagnosis and proton cancer therapy systems.

Drawing on knowledge accumulated through the development of cyclotrons for medical applications, SHI achieved a compact cyclotron with higher current by placing the negative hydrogen ion generator outside the device. In addition, in order to prevent destruction of the target beryllium plate by the high heat generated when a proton beam is applied to it, SHI implemented several measures, such as moving the proton beam in a circular orbit to avoid buildup of heat on the surface of the beryllium plate, a highly efficient spiral water-cooling system, and controlling the thickness of the beryllium plate so as to minimize the beam’s effect on the plate.

The cyclotron’s beam transport unit. It transports the proton beam generated by the accelerator.
The transported beam hits the beryllium plate to generate neutrons. These neutrons are irradiated to cancer cells.

After much trial and error, SHI succeeded in developing NeuCure, a compact BNCT system with a cyclotron. As a huge nuclear reactor is no longer required, this BNCT system can be installed in hospitals. The first unit of this system was delivered in 2009 to the Kyoto University Research Reactor Institute (now the Kyoto University Institute for Integrated Radiation and Nuclear Science), which was SHI’s development partner. Since then, the system has been delivered for clinical trials to Southern TOHOKU Hospital in Koriyama City, Fukushima Prefecture, in 2015, and to Osaka Medical College (now Osaka Medical and Pharmaceutical University) in Takatsuki City, Osaka Prefecture, in 2019.

In March 2020, SHI received approval from the Ministry of Health, Labour and Welfare for manufacture and sale of NeuCure as a new medical device, making it the first BNCT system in the world to gain approval as a medical device. Furthermore, in June 2020, national health insurance coverage of BNCT for cancer of the head and neck region was approved, and treatment has started at Southern Tohoku BNCT Research Center of Southern Tohoku Hospital and Kansai BNCT Research Center at Osaka Medical and Pharmaceutical University.

A boron agent is administered to the patient for BNCT two hours before irradiation. The body position, whether seated or lying, is selected in advance depending on the treatment area, and neutrons are irradiated.

Currently, BNCT is indicated for cancers of the head and neck region that have recurred after standard treatments, such as surgery, radiotherapy, and chemotherapy, and are unresectable. For the application of BNCT to brain tumors (recurrent malignant glioma), SAKIGAKE comprehensive assessment consultation by the Pharmaceuticals and Medical Devices Agency (PMDA) is also underway (as of December 2021). In order to meet the expectations of as many patients as possible with difficult-to-treat diseases, SHI will continue its efforts to expand the application of BNCT, and furthermore, aims to expand the use of BNCT not only in Japan but also elsewhere in the world.

Sumitomo Heavy Industries
https://www.shi.co.jp/english/
Since its origin in 1888 as a machine repair shop at the Besshi Copper Mine, Sumitomo Heavy Industries, Ltd. (SHI) has developed into an integrated manufacturer whose business encompasses industrial machinery such as power transmission and control equipment, plastics processing machines, industrial cranes, and hydraulic excavators, environmental facilities and plants, and ships. SHI has developed leading-edge systems to meet increasingly sophisticated and diversifying customer needs, including semiconductor and liquid crystal manufacturing equipment and medical systems. Through the pursuit of technology development, SHI will keep on contributing to the development of society and industry.

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