September 01, 2026

In December 2024, Sumitomo Heavy Industries, Ltd. (Head Office: Shinagawa-ku, Tokyo; Representative Director, President, and CEO: Toshiro Watanabe; hereinafter “SHI”) concluded a memorandum of understanding with Fujita Academy (Headquarters: Toyoake-shi, Aichi; Chairman, Board of Directors: Kiyotaka Hoshinaga) and other parties to promote research and development of a boron neutron capture therapy (BNCT) system for the treatment of deep-seated cancers. In January 2026, SHI also entered into a contract for the installation of a BNCT treatment system and BNCT dose calculation software, aimed at research and development for the treatment of deep-seated cancers.
The “Exploratory Study of [18F]FBPA (*1) Uptake in Deep-Seated Cancers” (hereinafter the “Study”), to be conducted by Fujita Health University, Fujita Academy (Toyoake-shi, Aichi; President: Nakao Iwata; hereinafter “Fujita Health University”), has now been approved by Fujita Health University’s Certified Review Board (*2).

The Study is a specified clinical trial using [18F]FBPA synthesized with “MPS200FBPA” (*3), a research-use synthesis device manufactured by SHI, and will evaluate the utility of [18F]FBPA in tumor diagnosis.
[18F]FBPA is also expected to indicatethe same biodistribution as the boron agent (BPA) used in BNCT, and the findings of the Study are expected to help enable the future effective utilization of BNCT to treat deep-seated cancers.

The Study will include patients with lesions in the abdomen below the diaphragm. Eligible cases will be those in which conventional diagnostic imaging cannot readily distinguish malignant tumors from non-neoplastic lesions.
The Study will use “[18F]FBPA,” a PET diagnostic agent made by labeling boronophenylalanine (BPA) (*4), which is used in BNCT, with fluorine-18. The Study will evaluate its diagnostic utility and seek to establish a new treatment alternative for deep-seated tumors.

SHI will work with Fujita Health University to ensure the smooth conduct of the Study and, through initiatives aimed at the continued advancement of BNCT, will contribute to the future of cancer treatment.

(*1) [18F]FBPA: A compound labeled with 18F, a radionuclide used in PET imaging, to visualize the accumulation of BPA. It visualizes the metabolism of amino acids consumed in large quantities by cancer cells. It is also expected to be useful for assessing the accumulation of the boron agent (BPA) used in BNCT.
(*2) Certified Review Board (CRB): A committee accredited by the Minister of Health, Labour and Welfare under the Clinical Trials Act that reviews clinical research plans from the standpoints of research participant safety, ethical considerations, scientific validity, and other factors.
(*3) MPS200FBPA: SHI’s research-use synthesis device, which synthesizes BPA labeled with 18F, a radionuclide used in PET imaging.
(*4) Boronophenylalanine (BPA): A drug made by binding boron to phenylalanine, an essential amino acid. In 1987, a group led by Professor Yutaka Mishima of Kobe University achieved the world’s first successful clinical application of BNCT to malignant melanoma.
(*5) Standardized Uptake Value (SUV): A semiquantitative value indicating the extent to which an administered agent accumulates in tissue such as a tumor. It is calculated as the ratio of the measured concentration to the concentration that would result if the administered agent were distributed uniformly throughout the body, with the latter set to 1.

[Related Information]
December 25, 2024: “SHI Concludes MOU on Boron Neutron Capture Therapy System with Fujita Health University, Atransen Pharma, Stella Pharma, and Fujita”
January 15, 2026: “Contract Concluded for a BNCT System at Fujita Health University”