Establishing the [(18)F]-FDG Production via Two Different Automated Synthesizers for Routine Clinical Studies: Our Institutional Experiences of 4 years

INTRODUCTION: [(18)F]-Fluorodeoxyglucose ([(18)F]-FDG) is the most widely used positron-emission tomography tracer used for imaging in clinical studies such as early detection of cancer or its malignancies, quantifications, staging, and restaging of several malignancies. For clinical application, routine production of this tracer is mandatory in compliance to regulatory guidelines. Several dedicated commercial synthesizers are currently used for producing[(18)F]-FDG for clinical usage. Being at hospital radiopharmacy, it is our responsibility and duty to support the clinical service with uninterrupted production and supply of [(18)F]-FDG. This document describes the production of [(18)F]-FDG using two different automated synthesizers in terms of its production yield, time of synthesis, and analyze the quality control (QC) of the produced [(18)F]-FDG. MATERIALS AND METHODS: The precursor, mannose triflate ultra-pure, authentic nonradioactive standard FDG and [(18)O]-water were obtained from ABX, Germany. Solvents and reagents were purchased from Sigma Aldrich India Ltd. and Fisher Scientific India Ltd., (Mumbai, Maharashtra, India). RESULTS: The protocol developed for the synthesis with MPS-100 synthesizer yield of [(18)F]-FDG is approximate about 45% End of Bombardment (EOB) with synthesis time of around 35 min, whereas with F300E synthesizer it is around 60% with synthesis time of 25 min. The quality of the tracer produced by both synthesizers is at par with the QC parameter for clinical applications. CONCLUSIONS: Finally, we have developed the production using two automated synthesis modules which have the capability to produce [(18)F]-FDG, to do the patient studies in good yield and purity. Our protocol is simple, reproducible, and robust.