The Japanese government has shown increasing expectations for the medical application of radioactive isotopes (RIs), as reflected in the 2024 Basic Policy on Economic and Fiscal Management and Reform. Additionally, the Fukushima Instutute for Research, Education and Innovation (F-REI) has launched RI-based diagnostic and therapeutic drug development projects, and the Ministry of Health, Labour and Welfare has proposed a draft guideline for clinical and non-clinical studies of radiopharmaceuticals for therapeutic use. Meanwhile, in Europe, three large-scale theranostics projects began in October 2024. These projects represent the first public-private research initiatives in RI drug discovery, with significant financial support of 60 million euros from the Horizon Europe project of the European Commission and the related industries. In terms of drug development, the Innovative Health Initiative (IHI) plays a key role in funding medical research projects as part of Horizon Europe. It designated the Thera4Care, Accelerate.EU, and ILLUMINATE projects, focusing on theranostics. Thera4Care aims to establish ecosystem for theranostics and expand its use across Europe. Accelerate.EU aims to develop targeted alpha therapy using astatine-211 (²¹¹At) for pancreatic, breast, and brain cancers, establishing a sustainable production network. The project plans to conduct phase1 clinical trials by 2028. ILLUMINATE focuses on optimizing lutetium-177 (¹⁷⁷Lu)-based therapies for prostate cancer while improving isotope production and supply chains. Japan has RI research initiatives sponsored by F-REI, but lacks strong industry participation and financial contribution mechanisms seen in Europe. It is desirable for researchers to inform companies and related organizations about commissioned projects, and for researchers themselves to improve the environment for joint research. The advancement of theranostics using RIs in Japan requires industry engagement, knowledge dissemination, and workforce training to facilitate clinical applications and foster international collaboration.

Objective: [⁶⁴Cu]Cu-ATSM is a radiotherapeutics under clinical trials. It is necessary to take appropriate measures to limit its exposure and ensures its airborne concentrations do not exceed legally permitted levels. Therefore, the purpose of this study was to measure the airborne radioactivity concentration in the inpatient room after administering [⁶⁴Cu]Cu-ATSM to patients. Methods: Three patients with malignant glioma were intravenously administered [⁶⁴Cu]Cu-ATSM (100 MBq/kg ± 10%) in an inpatient room, and the airborne radioactivity concentrations were measured at two locations in the room (in the center of the room and near the entrance of the room) using a filter collection method. Results: After administration of [⁶⁴Cu]Cu-ATSM, the airborne radioactivity concentrations measured were around or below the limit of detection (8.24×10⁻⁷ Bq/cm³ or lower) in all three patients, and all concentrations were consistently below 1/10,000 of the legal airborne concentration limit of ⁶⁴Cu (1×10⁻¹ Bq/cm³). Conclusion: The results of this study confirmed that the airborne concentration of [⁶⁴Cu]Cu-ATSM after administration to patients was below the legally permitted level.

This survey was performed in order to investigate the incidence of adverse reactions to radiopharmaceuticals in FY2023 in Japan. It was based on responses to questionnaires sent to nuclear medicine institutions. Replies were obtained from 971 institutions out of 1,181 to which the questionnaire had been sent. A total of 884,272 radiopharmaceutical administrations were reported. Fifteen cases of adverse reactions were reported. The incidence of adverse reactions per 100,000 cases was 1.7. No case of defective products was reported.