Menon, Sreeja, Mitra, Arpit, Sahu, Sudeep, Lad, Sangita, Chakraborty, Avik, Ray, Mukti, Banerjee, Sharmila. (1403). On the Optimization of the Protocol for Automated Radiosyntheses of [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE in a Modular-Lab Standard. , 12(2), 149-160. doi: 10.22038/aojnmb.2024.77059.1545
Sreeja Raj Menon; Arpit Mitra; Sudeep Sahu; Sangita Lad; Avik Chakraborty; Mukti Kanta Ray; Sharmila Banerjee. "On the Optimization of the Protocol for Automated Radiosyntheses of [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE in a Modular-Lab Standard". , 12, 2, 1403, 149-160. doi: 10.22038/aojnmb.2024.77059.1545
Menon, Sreeja, Mitra, Arpit, Sahu, Sudeep, Lad, Sangita, Chakraborty, Avik, Ray, Mukti, Banerjee, Sharmila. (1403). 'On the Optimization of the Protocol for Automated Radiosyntheses of [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE in a Modular-Lab Standard', , 12(2), pp. 149-160. doi: 10.22038/aojnmb.2024.77059.1545
Menon, Sreeja, Mitra, Arpit, Sahu, Sudeep, Lad, Sangita, Chakraborty, Avik, Ray, Mukti, Banerjee, Sharmila. On the Optimization of the Protocol for Automated Radiosyntheses of [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE in a Modular-Lab Standard. , 1403; 12(2): 149-160. doi: 10.22038/aojnmb.2024.77059.1545

On the Optimization of the Protocol for Automated Radiosyntheses of [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE in a Modular-Lab Standard

Asia Oceania Journal of Nuclear Medicine and Biology
مقاله 6، دوره 12، شماره 2، مهر 2024، صفحه 149-160    اصل مقاله (1.51 M)
نوع مقاله: Original Article
شناسه دیجیتال (DOI): 10.22038/aojnmb.2024.77059.1545
نویسندگان
Sreeja Raj Menon1، 2؛ Arpit Mitra3؛ Sudeep Sahu4؛ Sangita Lad4؛ Avik Chakraborty2، 4؛ Mukti Kanta Ray2، 4؛ Sharmila Banerjee* 2، 5
1Health Physics Division, Bhabha Atomic Research Centre, Mumbai, India
2Homi Bhabha National Institute, Mumbai, India
3Radiopharmaceutical Laboratory, Board of Radiation and Isotope Technology, Navi Mumbai, India
4Radiation Medicine Centre, Bhabha Atomic Research Centre, Mumbai, India
5Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre, Navi Mumbai, India
چکیده
Objective: The present work describes the automated radiochemical syntheses of different PET tracers like [68Ga]Ga-Pentixafor, [68Ga]Ga-FAPI-4 and [68Ga]Ga-DOTATATE using optimized single protocol in the non-cassette based Eckert & Ziegler (EZ) Modular Lab (fixed tubing system) without any modification in the inbuilt human machine interface (HMI) software. Recently, PET agents viz. [68Ga]Ga-Pentixafor and [68Ga]Ga-FAPI-4 are gaining prominence for the diagnosis of overexpressed Chemokine Receptor-4 (CXCR4) and Fibroblast Activation Protein (FAP) receptor, respectively, in the microenvironment of numerous cancer types. The promising results observed with the clinical usage of [68Ga]Ga-DOTATATE produced using the automated protocol, provided impetus for the clinical translation of [68Ga]Ga-Pentixafor and [68Ga]Ga-FAPI-4 using the in-house developed automated radiolabeling protocol.
Methods: Herein we report a single radiolabeling protocol for the automated preparation of [68Ga]Ga-Pentixafor and [68Ga]Ga-FAPI-4 in the non-cassette based EZ Modular-Lab Standard radiochemistry module, without any changes in schematic, graphical user interface (GUI) software and time list, from that used for routine production of [68Ga]Ga-DOTATATE in our centre, since 2015. Physico-chemical quality control and in-vitro stability analyses were carried out using radio-TLC and radio-HPLC.
Results: The automated protocol yielded reliable and consistent non-decay corrected (ndc) radiochemical yield (RCY) of (84.4±0.9)% and (85.5±1.4)% respectively, for [68Ga]Ga-Pentixafor and [68Ga]Ga-FAPI-4, with RCP> 98%, which are comparable to the RCY of (84.4±1.2)% and RCP (99.1±0.3)% for [68Ga]Ga-DOTATATE. The biological quality control studies confirmed the formulations to be of ready-to-use pharmaceutical grade.
Conclusion: The consistent and reliable RCY and RCP of multiple 68Ga-labeled PET tracers by single optimized automated radiochemistry protocol exhibits the versatility of the EZ Modular Lab.
کلیدواژه‌ها
[68Ga]Ga-Pentixafor؛ [68Ga]Ga-FAPI-4؛ [68Ga]Ga-DOTATATE؛ Modular-Lab Standard؛ PET/CT
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