On the Optimization of the Protocol for Automated Radiosyntheses of [۶۸Ga]Ga-Pentixafor, [۶۸Ga]Ga-FAPI-۴ and [۶۸Ga]Ga-DOTATATE in a Modular-Lab Standard
- سال انتشار: 1403
- محل انتشار: مجله پزشکی هسته ای و زیست شناسی آسیا اقیانوسیه، دوره: 12، شماره: 2
- کد COI اختصاصی: JR_JNMB-12-2_006
- زبان مقاله: انگلیسی
- تعداد مشاهده: 128
نویسندگان
Health Physics Division, Bhabha Atomic Research Centre, Mumbai, India
Radiopharmaceutical Laboratory, Board of Radiation and Isotope Technology, Navi Mumbai, India
Radiation Medicine Centre, Bhabha Atomic Research Centre, Mumbai, India
Radiation Medicine Centre, Bhabha Atomic Research Centre, Mumbai, India
Homi Bhabha National Institute, Mumbai, India
Homi Bhabha National Institute, Mumbai, India
Homi Bhabha National Institute, Mumbai, India
چکیده
Objective: The present work describes the automated radiochemical syntheses of different PET tracers like [۶۸Ga]Ga-Pentixafor, [۶۸Ga]Ga-FAPI-۴ and [۶۸Ga]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. [۶۸Ga]Ga-Pentixafor and [۶۸Ga]Ga-FAPI-۴ are gaining prominence for the diagnosis of overexpressed Chemokine Receptor-۴ (CXCR۴) and Fibroblast Activation Protein (FAP) receptor, respectively, in the microenvironment of numerous cancer types. The promising results observed with the clinical usage of [۶۸Ga]Ga-DOTATATE produced using the automated protocol, provided impetus for the clinical translation of [۶۸Ga]Ga-Pentixafor and [۶۸Ga]Ga-FAPI-۴ using the in-house developed automated radiolabeling protocol.Methods: Herein we report a single radiolabeling protocol for the automated preparation of [۶۸Ga]Ga-Pentixafor and [۶۸Ga]Ga-FAPI-۴ 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 [۶۸Ga]Ga-DOTATATE in our centre, since ۲۰۱۵. 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 (۸۴.۴±۰.۹)% and (۸۵.۵±۱.۴)% respectively, for [۶۸Ga]Ga-Pentixafor and [۶۸Ga]Ga-FAPI-۴, with RCP> ۹۸%, which are comparable to the RCY of (۸۴.۴±۱.۲)% and RCP (۹۹.۱±۰.۳)% for [۶۸Ga]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 ۶۸Ga-labeled PET tracers by single optimized automated radiochemistry protocol exhibits the versatility of the EZ Modular Lab.کلیدواژه ها
[۶۸Ga]Ga-Pentixafor, [۶۸Ga]Ga-FAPI-۴, [۶۸Ga]Ga-DOTATATE, Modular-Lab Standard, PET/CTاطلاعات بیشتر در مورد COI
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