Revy Alban, Hallouard François, Joyeux-Klamber Sandrine, Skanjeti Andrea, Rioufol Catherine, Fraysse Marc
Hospices Civils de Lyon, Centre Hospitalier de Lyon Sud, Service de Pharmacie, unite de radiopharmacie, 165 Chemin du Grand Revoyet F-69310 Pierre-Benite, France.
Hospices Civils de Lyon, Centre Hospitalier de Lyon Sud, Service de radioprotection, 165 Chemin du Grand Revoyet F-69310 Pierre-Benite, France.
Curr Radiopharm. 2019;12(3):229-237. doi: 10.2174/1874471012666190110170623.
Recent gallium-68 labeled peptides are of increasing interest in PET imaging in nuclear medicine. Somakit TOC® is a radiopharmaceutical kit registered in the European Union for the preparation of [68Ga]Ga-DOTA-TOC used for the diagnosis of neuroendocrine tumors. Development of a labeling process using a synthesizer is particularly interesting for the quality and reproducibility of the final product although only manual processes are described in the Summary of Product (SmPC) of the registered product. The aim of the present study was therefore to evaluate the feasibility and value of using an automated synthesizer for the preparation of [68Ga]Ga-DOTA-TOC according to the SmPC of the Somakit TOC®.
Three methods of preparation were compared; each followed the SmPC of the Somakit TOC®. Over time, overheads, and overexposure were evaluated for each method.
Mean±SD preparation time was 26.2±0.3 minutes for the manual method, 28±0.5 minutes for the semi-automated, and 40.3±0.2 minutes for the automated method. Overcost of the semi-automated method is 0.25€ per preparation for consumables and from 0.58€ to 0.92€ for personnel costs according to the operator (respectively, technician or pharmacist). For the automated method, overcost is 70€ for consumables and from 4.06€ to 6.44€ for personnel. For the manual method, extremity exposure was 0.425mSv for the right finger, and 0.350mSv for the left finger; for both the semi-automated and automated method extremity exposure were below the limit of quantification.
The present study reports for the first time both the feasibility of using a [68Ga]- radiopharmaceutical kit with a synthesizer and the limits for the development of a fully automated process.
近期，镓 - 68标记的肽在核医学的正电子发射断层显像（PET）成像中越来越受关注。Somakit TOC®是一种在欧盟注册的放射性药物试剂盒，用于制备[68Ga]Ga - DOTA - TOC，用于神经内分泌肿瘤的诊断。尽管注册产品的产品特性摘要（SmPC）中仅描述了手动制备过程，但使用合成仪进行标记过程的开发对于最终产品的质量和可重复性特别有意义。因此，本研究的目的是根据Somakit TOC®的SmPC评估使用自动合成仪制备[68Ga]Ga - DOTA - TOC的可行性和价值。
比较了三种制备方法；每种方法均遵循Somakit TOC®的SmPC。随着时间的推移，对每种方法的间接费用和过度暴露进行了评估。
手动方法的平均±标准差制备时间为26.2±0.3分钟，半自动方法为28±0.5分钟，自动方法为40.3±0.2分钟。半自动方法的耗材每次制备的额外成本为0.25欧元，根据操作人员（分别为技术员或药剂师）的不同，人员成本为0.58欧元至0.92欧元。对于自动方法，耗材的额外成本为70欧元，人员成本为4.06欧元至6.44欧元。对于手动方法，右手手指的肢体暴露量为0.425毫希沃特，左手手指为0.350毫希沃特；半自动和自动方法的肢体暴露量均低于定量限。
本研究首次报告了使用[68Ga]放射性药物试剂盒与合成仪的可行性以及全自动过程开发的局限性。
