Clinical ⁶⁸Ga-PET: Is radiosynthesis module an absolute necessity?

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• 作者：Rubel Chakravarty^a ; ^{rubelc@barc.gov.in} ; Sudipta Chakraborty^a ; ^{sudipta@barc.gov.in} ; ER Radhakrishnan^b ; Koramadai Kamaleshwaran^b ; Ajit Shinto^b ; Ashutosh Dash^a
• 关键词：68Ge/68Ga generator ; Pet ; 68Ga-DOTANOC ; 68Ga-NODAGA-RGD2 ; 68Ga-DKFZ-PSMA-11 ; 68Ga-BPAMD
• 刊名：Nuclear Medicine and Biology
• 出版年：2017
• 出版时间：March 2017
• 年：2017
• 卷：46
• 期：Complete
• 页码：1-11
• 全文大小：1220 K
• 卷排序：46

文摘

The commercially available 68Ge/68Ga generators are generally used in clinical context in conjunction with automated or semi-automated modules for the syntheses of 68Ga radiopharmaceuticals. It is desirable to develop strategies for the formulation of 68Ga-radiopharmaceuticals without use of such expensive modules in order to make 68Ga-based clinical positron emission tomography (PET) more popular and affordable worldwide.MethodsAn organic matrix based 68Ge/68Ga generator was used for preparation of clinically relevant doses of four different 68Ga-based radiopharmaceuticals, namely 68Ga-DOTA-NOC, 68Ga-NODAGA-RGD2, 68Ga-PSMA-11 and 68Ga-BPAMD. Detailed performance evaluation of the generator was carried out over the period of 9 months. The radiolabeling conditions were optimized in a hospital radiopharmacy directly utilizing 68Ga eluted from the generator without use of any synthesis module. Quality control tests of the radiopharmaceuticals were carried out to assess their suitability for clinical use. The clinical utility of the synthesized radiopharmaceuticals was ascertained by performing PET scans in human patients.ResultsDuring the period of evaluation, 68Ga could be obtained from the generator in 4 mL of 0.05 M HCl with 60–85% elution yield and >99.99% radionuclidic purity. While directly using 68Ga eluted from the generator, the 68Ga-based radiopharmaceuticals could be prepared with >95% radiochemical purity and they met all the requirements for clinical administration. The clinical efficacy of the radiopharmaceuticals synthesized was established by PET scans in human patients. The performance of the generator remained consistent over the 9-month period and >100 clinical doses of different radiopharmaceuticals were prepared with excellent reproducibility and clinical effectiveness.ConclusionsThe promising results obtained in this study would make 68Ga-radiopharmacy more practical and cost effective in clinical context. To the best of our knowledge, this is the first report on the clinical scale syntheses and utilization of 68Ga-based radiopharmaceuticals without using any synthesis module.