Rationale for Translational Research on Targeted Alpha Therapy in Japan —Renaissance of Radiopharmaceuticals Utilizing Astatine-211 and Actinium-225—

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  • Yano Tsuneo
    QiSS-Targeted Alpha Therapy Research, Research Center for Nuclear Physics, Osaka University
  • Hasegawa Koki
    Center for Instrumental Analysis, Kyoto Pharmaceutical University
  • Sato Tatsuhiko
    QiSS-Targeted Alpha Therapy Research, Research Center for Nuclear Physics, Osaka University Nuclear Science and Engineering Center, Japan Atomic Energy Agency
  • Tatsumi Mitsuaki
    Department of Radiology, Osaka University Hospital
  • Watabe Tadashi
    Department of Nuclear Medicine and Tracer Kinetics, Graduate School of Medicine, Osaka University
  • Kadonaga Yuichiro
    Institute for Radiation Sciences, Osaka University
  • Kabayama Kazuya
    Department of Chemistry, Graduate School of Science, Osaka University
  • Fukase Koichi
    Department of Chemistry, Graduate School of Science, Osaka University
  • Hachisuka Akiko
    Division of Biochemistry, National Institute of Health Sciences
  • Hirabayashi Yoko
    Center for Biological Safety & Research, National Institute of Health Sciences
  • Fujii Hirofumi
    Division of Functional Imaging, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center
  • Yonekura Yoshiharu
    Institute for Radiation Sciences, Osaka University

Bibliographic Information

Other Title
  • 日本におけるアルファ線核医学治療薬剤のトランスレーショナルリサーチの基盤—アスタチン-211とアクチニウム225を活用した治療用放射性医薬品の萌芽—
  • Rationale for Translational Research on Targeted Alpha Therapy in Japan : Renaissance of Radiopharmaceuticals Utilizing Astatine-211 and Actinium-225

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Description

<p>We wish to herewith report safety evaluations, microdosimetry, and clinical requirements for first-in-human (FIH) study for handling of targeted alpha therapy (TAT) drug products labelled by 211At and 225Ac. 1) The safety evaluation method is proposed including delayed toxicity using the histopathological examination. The biodistribution study using PET or SPECT corresponding to alpha nuclides is also proposed. 2) Two scales of microdosimetry are proposed for the TAT design; one is the organ-microstructure scales and the other is the cellular and subcellular scales. Recently, the stochastic microdosimetric kinetic model was developed by the cellular-scale particle transport simulation using PHITS. 3) The dose of TAT drug for FIH study can be considered in the amount of radioactivity and mass, and radioactivity would often be a more important determining factor than mass. 4) In Japan, Medical Device system for regulatory approval of the synthesizer itself has been adopted as well as Medical Drug system for delivery of radiopharmaceuticals. We propose to start an automatic synthesis device at an early stage and to establish manufacturing process, quality control and GMP evaluations. The need for radiation shielding based on the calculation by effective dose rate coefficients for alpha particles is also introduced. The argument is concluded that the operation in hot cell used at many PET centers is sufficient.</p>

Journal

  • RADIOISOTOPES

    RADIOISOTOPES 69 (10), 329-340, 2020-10-15

    Japan Radioisotope Association

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