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Assessment of radionuclide impurities in [18F]fluoromethylcholine ([18F]FMCH)
Institution:1. Medical Physics Department, Perugia General Hospital, Perugia, Italy;2. Physics Department, University of Turin, Turin, Italy;3. Medical Physics Unit, Azienda Usl Toscana sud est, San Donato Hospital, Arezzo, Italy;4. Department of Surgical and Biomedical Science – Radiation Oncology Section, University of Perugia, Italy;5. Ionizing Radiation Service, Regional Agency for the Environmental Protection of Umbria, Perugia, Italy;1. School of Biomedical Engineering, Southern Medical University, Guangzhou 510515, China;2. Guangdong Provincial Key Laboratory of Medical Image Processing, Southern Medical University, Guangzhou 510515, China;3. The Sixth affiliated Hospital of Sun Yat-sen University, Guangzhou 510655, China;1. Medical Physics and Radiation Protection Department, University Hospital Rijeka, Krešimirova 42, Rijeka, Croatia;2. Medical Physics and Biophysics Department, Medical Faculty, University of Rijeka, Braće Branchetta 20, Rijeka, Croatia;3. Radiology Department, University Hospital Rijeka, Krešimirova 42, Rijeka, Croatia;4. Radiology Department, Medical Faculty, University of Rijeka, Braće Branchetta 20, Rijeka, Croatia;5. Radiology Department, General Hospital Pula, Santoriova 24a, Pula, Croatia;6. Department of Medical Physics, Azienda Ospedaliero Universitaria Maggiore della Carità, Novara, Italy;7. Massachusetts General Hospital, Boston, MA, USA;8. Harvard Medical School, Boston, MA, USA;1. Division of Cancer Science, University of Manchester, Manchester, UK;2. Radiotherapy Related Research, The Christie Foundation Trust, Manchester, UK;3. Christie Medical Physics & Engineering, The Christie NHS Foundation Trust, Manchester, UK
Abstract:Purpose18F]Fluoromethylcholine (18F]FMCH) is a radiopharmaceutical used in positron emission tomography (PET) imaging for the study of prostate, breast, and brain tumors. It is usually synthesized in cyclotron facilities where 18F is produced by proton irradiation of 18O]H2O through 18O(p,n)18F reaction. Due to the activation of target materials, the bombardment causes unwanted radionuclidic impurities in 18O]H2O, that need to be removed during the radiopharmaceutical synthesis. Thus, the aim of this study is to quantify the radionuclide impurities in the 18F production process and in the synthesized 18F]FMCH, demonstrating the radionuclidic purity of this radiopharmaceutical.MethodsLong-lived radionuclide impurities were experimentally assessed using high-resolution gamma and liquid scintillation spectrometries, while short-lived impurities were monitored analyzing the decay curve of the irradiated 18O]H2O with an activity calibrator. As spectrometric radionuclide library, a Geant4 Monte Carlo simulation of the 18F-target assembly was previously performed.Results3H, 52,54Mn, 56,57,58Co, 95m,96Tc, 109Cd, and 184Re were found in the irradiated 18O]H2O, but no radionuclide was found in the non-irradiated 18O]H2O neither in the final 18F]FMCH solution with an activity concentration greater than the minimum detectable activity concentration. A total impurity activity <6.2 kBq was measured in the irradiated 18O]H2O, whereas a 18F]FMCH radionuclide purity >99.9999998% was estimated. Finally, the decay curve of the irradiated 18O]H2O revealed a very low maximum of 13N activity (<0.03% of 18F) even immediately after the end of bombardment.ConclusionsThis study demonstrated the radionuclidic purity of 18F]FMCH according to the EU Pharmacopeia.
Keywords:Medical cyclotron  PET radiopharmaceuticals  Radionuclidic purity
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