Lymph node dissection is a therapeutic option for prostate cancer patients with a high risk of- or proven lymph node metastases. Radioguided surgery after intravenous injection of [99mTc]Tc-PSMA could improve the selectivity of lymph node dissection. The aim of this project was to develop an automated synthesis method for [99mTc]Tc-PSMA, using the disposables and chemicals used at our institute for [68Ga]Ga-PSMA labeling. Furthermore, quality control procedures and validation results of the automated production of [99mTc]Tc-PSMA conform cGMP and cGRPP are presented. [99mTc]Tc-PSMA is produced fully automatic with a Scintomics synthesis module. Quality control procedures are described and performed for: activity, labeling yield, visual inspection, pH measurement, sterility and endotoxin determination, radionuclide purity, radiochemical purity (99mTc-colloids, unbound [99mTc]pertechnetate, and other impurities), and HEPES content. Three batches of [99mTc]Tc-PSMA were prepared on three separate days for validation and stability testing at 0, 4, 6, and 24 h. [99mTc]Tc-PSMA can be successfully manufactured automatically within a [68Ga]Ga-PSMA workflow with the addition of only [99mTc]pertechnetate and stannous chloride. The radiochemical purity after production was highly reproducible (96.3%, 97.6%, and 98.2%) and remained > 90% (required for patient administration) up to 6 h later. A fully automated labeling procedure with corresponding quality control methods for production of [99mTc]Tc-PSMA is presented, which is validated according to cGMP and cGRPP guidelines and can be implemented in a GMP environment. The produced [99mTc]Tc-PSMA is stable for up to 6 h. The presented procedure is almost identical to the automated production of [68Ga]Ga-PSMA and can therefore be implemented expediently if a workflow for [68Ga]Ga-PSMA is already in place.

中文翻译：

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[99mTc] Tc-PSMA的自动合成和质量控制，用于放射性手术（在[68Ga] Ga-PSMA工作流程中）。

淋巴结清扫术是前列腺癌患者淋巴结转移风险高或已证实的治疗选择。静脉内注射[99mTc] Tc-PSMA的放射引导手术可以提高淋巴结清扫的选择性。这个项目的目的是开发一种自动合成[99mTc] Tc-PSMA的方法，使用我们研究所用于[68Ga] Ga-PSMA标记的一次性用品和化学药品。此外，介绍了自动生产符合[99mTc] Tc-PSMA的cGMP和cGRPP的质量控制程序和验证结果。[99mTc] Tc-PSMA通过Scintomics合成模块全自动生产。描述和执行质量控制程序，包括：活性，标记收率，目测，pH测量，无菌和内毒素测定，放射性核素纯度，放射化学纯度（99mTc胶体，未结合的[99mTc]高tech酸盐和其他杂质）和HEPES含量。在三天中分别制备了三批[99mTc] Tc-PSMA，用于在0、4、6和24小时进行验证和稳定性测试。仅加入[99mTc]高tech酸酯和氯化亚锡，就可以在[68Ga] Ga-PSMA工作流程中自动成功制造[99mTc] Tc-PSMA。生产后的放射化学纯度可高度重现（96.3％，97.6％和98.2％），直至6小时后仍保持> 90％（患者给药所需）。提出了一种用于生产[99mTc] Tc-PSMA的全自动标记程序和相应的质量控制方法，该程序已根据cGMP和cGRPP准则进行了验证，并且可以在GMP环境中实施。产生的[99mTc] Tc-PSMA稳定长达6小时。