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首页> 外文期刊>International journal of molecular imaging >Synthesis of Clinical-Grade [18F]-Fluoroestradiol as a Surrogate PET Biomarker for the Evaluation of Estrogen Receptor-Targeting Therapeutic Drug
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Synthesis of Clinical-Grade [18F]-Fluoroestradiol as a Surrogate PET Biomarker for the Evaluation of Estrogen Receptor-Targeting Therapeutic Drug

机译：临床级[18F]-氟雌二醇的合成作为替代PET生物标志物，用于评估靶向雌激素受体的治疗药物

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16α-[18F]-fluoroestradiol ([18F]FES), a steroid-based positron emission tomography (PET) tracer, has emerged as a dependable tracer for the evaluation and management of estrogen receptor-positive (ER+) breast cancer patients. We have developed a fully automatic, one-pot procedure for the synthesis of [18F]FES using the Eckert & Ziegler (E & Z) radiomodular system. After [18F]fluorination, the intermediate was hydrolyzed with 2.0 M HCl twice and neutralized with sodium bicarbonate. After high-performance liquid chromatography (HPLC) purification, the decay-corrected radiochemical yield and purity of [18F]FES were 40 ± 5.0% (n=12) and >97%, respectively. The product was stable up to 10 h. Total synthesis time including HPLC purification was 80 min. This new, fully automated rapid synthetic procedure provided high and reproducible yields of [18F]FES. Quality control (QC) tests showed that the [18F]FES produced by this method met all specifications for human injection.
机译：16α-[18F]-氟雌二醇（[18F] FES）是一种基于类固醇的正电子发射断层扫描（PET）示踪剂，已成为评估和管理雌激素受体阳性（ER +）乳腺癌患者的可靠示踪剂。我们已经开发了使用Eckert＆Ziegler（E＆Z）放射性模块系统合成[18F] FES的全自动一锅法。 [18 F]氟化后，将中间体用2.0 4 M HCl水解两次，并用碳酸氢钠中和。高效液相色谱（HPLC）纯化后，经衰变校正的[18F] FES放射化学收率和纯度分别为40±5.0％（n = 12）和> 97％。该产品在10 h内稳定。包括HPLC纯化在内的总合成时间为80分钟。这种新型的全自动快速合成程序可提供[18F] FES的高产量且可重现的结果。质量控制（QC）测试表明，用此方法生产的[18F] FES符合人体注射的所有规格。

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