Vorster Mariza, Mokaleng Brenda, Sathekge Mike M, Ebenhan Thomas
University of Pretoria and Steve Biko Academic Hospital Private Bag X169 Pretoria, 0001, South Africa.
Hell J Nucl Med. 2013 Sep-Dec;16(3):193-8.
Our aim was to develop a practical method to prepare 68Ga-citrate using a SnO2-based 68Ge/68Ga generator and evaluate its use in infection imaging. 68Ga-citrate synthesis was performed in a straight forward, quantitative, one-step-aseptic procedure; an amended labeling method was applied using ACD-A buffered citrate as a precursor. Study participants were imaged on a Siemens Biograph 40 PET/CT scanner 60 min post intravenous injection. Our results showed: 90%-95% 68Ga-yield was obtained and subsequently used at 324-527 MBq to perform three to four parallel 68Ga-citrate syntheses. 68Ga-citrate of 96%-99% was yielded after 10 min incubation. The radiochemical purity was >99% with a pH value of 4.0-4.5. All other quality control requirements were met. The 68Ga-citrate stability was >96%. The final product was sterile, pyrogen and solvent-free, with very low 68Ge-levels, with 191±33 MBq in 6.6±2.8 mL. High quality images were obtained at 60 min post injection of 185 MBq of 68Ga-citrate. In conclusion, a fast, direct and cheap method with a quantitative preparation of 68Ga-citrate was described. We reported on the adaptations needed when using a SnO2-based 68Ge/68Ga generator and ACD-A buffered citrate as a precursor. This method allowed for multiple patient productions from one generator elution, with 300 MBq/patient of 68Ga-citrate produced in less than 30 min and excellent labeling reproducibility for routine infection imaging.
我们的目标是开发一种实用方法，利用基于SnO2的68Ge/68Ga发生器制备68Ga-柠檬酸盐，并评估其在感染成像中的应用。68Ga-柠檬酸盐的合成采用直接、定量、一步无菌程序进行；使用ACD-A缓冲柠檬酸盐作为前体应用了一种改进的标记方法。研究参与者在静脉注射后60分钟在西门子Biograph 40 PET/CT扫描仪上进行成像。我们的结果显示：获得了90%-95%的68Ga产率，随后以324-527 MBq用于进行三到四次平行的68Ga-柠檬酸盐合成。孵育10分钟后产生了96%-99%的68Ga-柠檬酸盐。放射化学纯度>99%，pH值为4.0-4.5。满足所有其他质量控制要求。68Ga-柠檬酸盐的稳定性>96%。最终产品无菌、无热原、无溶剂，68Ge水平极低，6.6±2.8 mL中为191±33 MBq。注射185 MBq的68Ga-柠檬酸盐后60分钟获得了高质量图像。总之，描述了一种快速、直接且廉价的定量制备68Ga-柠檬酸盐的方法。我们报告了使用基于SnO₂的68Ge/68Ga发生器和ACD-A缓冲柠檬酸盐作为前体时所需的调整。该方法允许从一次发生器洗脱中为多名患者生产，在不到30分钟内生产出300 MBq/患者的68Ga-柠檬酸盐，并且在常规感染成像中具有出色的标记重现性。
