Comprehensive integration of safety, optimization, and regulation in ¹⁷⁷Lu-based theranostic radiopharmaceuticals: from production to dose assessment

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In recent decades, medical radioisotopes have transformed cancer diagnosis and treatment. The advent of theranostic radionuclides, enabling both diagnostic and targeted radiotherapy with a single radionuclide, merges two nuclear medicine fields, enhancing personalized targeted radiotherapy through internal dosimetry. Among these agents, the short-lived β-emitter ¹⁷⁷Lu is a promising theranostic agent for various oncological diseases. This research covers advanced production techniques, radiation safety, transportation, Canadian regulations, and internal dose assessment in radiopharmaceutical clinical applications. The study reviews regulations for obtaining a license from the Canadian Nuclear Safety Commission for a radiopharmaceutical therapy facility. It also examines internal dose assessment in nuclear medicine, explaining each step and providing an introduction to common software codes, along with a comparison of commercial software packages. Two case studies compare software codes and internal dose assessment results, emphasizing the ongoing challenge of determining accurate organ-absorbed doses in the RPT process. The ultimate goal is to comprehensively integrate key aspects of ¹⁷⁷Lu targeted therapy into a unified overview, bridging a crucial gap in understanding.