Clinical Practice Guidelines for 18F-Fluciclovine 2024 in the Japanese Society of Nuclear Medicine

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Abstract 18F-Fluciclovine was the first 18F-labeled amino acid PET tracer to be approved for clinical use in Japan, receiving regulatory approval in March 2021 and being listed for reimbursement in June 2024. In response to this development, the Japanese Society of Nuclear Medicine initiated the formulation of clinical guidelines to ensure the appropriate use of this radiopharmaceutical in clinical practice. This guideline provides a comprehensive overview of the clinical characteristics of 18F-Fluciclovine in malignant glioma, including indications for use, imaging protocols, interpretation of PET images, and considerations for radiation safety. The Japanese version of this guideline was compiled by a voluntary editorial committee and officially approved by the Japanese Society of Nuclear Medicine on August 16, 2024. The primary objective of this guideline is to consolidate the current scientific evidence on 18F-Fluciclovine and to clarify its clinical utility, appropriate usage, and imaging methodologies. By doing so, it aims to promote the proper implementation of 18F-Fluciclovine in clinical settings and to serve as a reference for future applications related to the expansion of insurance coverage and reimbursement decisions. It is recommended that PET examinations using 18F-Fluciclovine in Japan be conducted in accordance with this guideline. Although the content is tailored to the Japanese medical system and regulatory framework, the imaging protocols, radiation safety management, and interpretation methods described herein are also expected to be internationally applicable and relevant.

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