Zheng Qi-Huang, Wang Min, Glick-Wilson Barbara E, Arkins Chase A, Klueppelberg Eric R, Snyder Scott E, Schulte Michael L
Department of Radiology and Imaging Sciences, Indiana University School of Medicine Indianapolis, IN, USA.
Am J Nucl Med Mol Imaging. 2025 Aug 15;15(4):158-166. doi: 10.62347/SPOE8395. eCollection 2025.
-(2-[F]Fluoroethyl)- -tyrosine ([F]FET) is a promising amino acid PET tracer for assessment of malignant brain tumors. Herein, we report optimized production of [F]FET for clinical use on two commercial radiochemistry systems: Sofie ELIXYS and GE FASTlab 2. While the Sofie ELIXYS procedure requires high performance liquid chromatography (HPLC) purification, the GE FASTlab 2 method uses solid-phase extraction (SPE) purification. In both cases, [F]FET met release specifications for clinical investigation laid out in the United States Pharmacopeia (USP) and/or European Pharmacopeia (Ph. Eur.). The radiochemical yield of [F]FET was 35-55% and 30-55% decay corrected to start of synthesis (SOS) for Sofie ELIXYS and GE FASTlab 2, respectively. The overall synthesis time was 75-85 and 70-80 min from SOS for Sofie ELIXYS and GE FASTlab 2, respectively. The radiochemical purity was > 99%, and the molar activity (A) was 340-464 GBq/µmol at end of synthesis (EOS).
-（2-[F]氟乙基）-α-酪氨酸（[F]FET）是一种用于评估恶性脑肿瘤的很有前景的氨基酸正电子发射断层显像（PET）示踪剂。在此，我们报告了在两种商业放射化学系统（Sofie ELIXYS和GE FASTlab 2）上用于临床的[F]FET的优化生产方法。虽然Sofie ELIXYS程序需要高效液相色谱（HPLC）纯化，但GE FASTlab 2方法使用固相萃取（SPE）纯化。在这两种情况下，[F]FET均符合美国药典（USP）和/或欧洲药典（Ph. Eur.）规定的临床研究释放规格。[F]FET的放射化学产率分别为35 - 55%和30 - 55%（衰变校正至合成开始（SOS）），分别对应Sofie ELIXYS和GE FASTlab 2。从SOS起，Sofie ELIXYS和GE FASTlab 2的总合成时间分别为75 - 85分钟和70 - 80分钟。放射化学纯度>99%，合成结束时（EOS）的摩尔活度（A）为340 - 464 GBq/µmol。
