Szydło Marcin, Jadwiński Michał, Chmura Agnieszka, Gorczewski Kamil, Sokół Maria
PET Diagnostics Department, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Gliwice Branch, Poland.
Department of Medical Physics, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Gliwice Branch, Poland.
Contemp Oncol (Pozn). 2016;20(3):229-36. doi: 10.5114/wo.2016.61566. Epub 2016 Aug 4.
[(11)C]-choline is an effective PET tracer used for imaging of neoplastic lesions and metastases of the prostate cancer. However, its production can be a challenge for manufacturers, as it has not yet been described in Polish or European pharmacopoeia. In this study the technical aspects of [(11)C]-choline production are described and detailed process parameters are provided. The quality control procedures for releasing [(11)C]-choline as solutio iniectabilis are also presented. The purity and quality of the radiopharmaceutical obtained according to the proposed method were find to be high enough to safely administrate the radiopharmaceutical to patients. Application of an automated synthesizer makes it possible to carry out the entire process of [(11)C]-choline production, isolation and purification within 20 minutes. It is crucial to maintain all aspects of the process as short as possible, since the decay half-time of carbon-11 is 20.4 minutes. The resulting radiopharmaceutical is sterile and pyrogen-free and of a high chemical, radiochemical, and radionuclide purity proved by chromatographic techniques. The yield of the process is up to 20%. [(11)C]-choline PET scanning can be used as accurate and effective diagnostic tool in all centers equipped with [(11)C]-target containing cyclotron.
[11C] - 胆碱是一种用于前列腺癌肿瘤病变和转移灶成像的有效正电子发射断层扫描（PET）示踪剂。然而，其生产对制造商来说可能是一项挑战，因为波兰或欧洲药典中尚未对其进行描述。本研究描述了[11C] - 胆碱生产的技术方面，并提供了详细的工艺参数。还介绍了作为注射用溶液放行[11C] - 胆碱的质量控制程序。根据所提出的方法获得的放射性药物的纯度和质量被发现足够高，可以安全地给患者施用该放射性药物。使用自动合成仪可以在20分钟内完成[11C] - 胆碱生产、分离和纯化的整个过程。由于碳 - 11的衰变半衰期为20.4分钟，尽可能缩短过程的各个方面至关重要。所得放射性药物无菌、无热原，并且通过色谱技术证明具有高化学、放射化学和放射性核素纯度。该过程的产率高达20%。[11C] - 胆碱PET扫描可以在所有配备含[11C]靶回旋加速器的中心用作准确有效的诊断工具。
