乳腺癌<superscript>18</superscript>F-FES雌激素受体PET技术和应用 标准. (Chinese)

Estrogen receptor (ER) is overexpressed in approximately 2/3 of breast cancer patients' lesions. Noninvasive detection of ER in vivo and dynamic monitoring of ER are crucial for individualized treatment decision-making. 16α- 18 F-17β-fluoroestradiol ( 18 F-FES) positron emission tomography (PET) has been used in a variety of preclinical and clinical studies to detect ER expression. However, there is still a lack of technical specifications in China. This technical specification was jointly written by domestic experts who had experience of 18 F-FES PET imaging and was formed through consultation based on their own experience and research progress in this field both domestically and internationally. This technical specification introduced the synthesis method and quality control requirements of 18 F-FES, recommended its clinical application scenarios, and classified them. In addition, experts' suggestions were provided throughout the entire process systemically and detailly, including pre-imaging preparation, imaging process, image analysis (normal biological distribution, determination of ER positive and negative, lesion detection, influencing factors, false negative and false positive, report requirements), and the limitations of this imaging technique were proposed. The future application prospects were also discussed. This specification aimed to promote the standardized application of 18 F-FES PET in China, achieve repeatability and comparability, and provide important molecular imaging technical support for accurate diagnosis and treatment of breast cancer. [ABSTRACT FROM AUTHOR]

约2/3的乳腺癌患者病灶为雌激素受体（estrogen receptor, ER）阳性。在活体内无创检测ER, 并对其生物活性 进行动态监测对作出个体化治疗决策至关重要。国内已有系列临床前和临床研究提示16α- 18 F-17β-氟雌二醇（16α- 18 F-17β-fluoroestradiol, 18 F-FES）正电子发射体层成像（positron emission tomography, PET）可用于ER表达分析, 但尚缺乏相应技 术规范。本技术标准由国内开展 18 F-FES PET研究与应用的专家共同执笔, 参考自身经验及国内外该领域研究进展后共同商 议制定。本技术标准介绍了 18 F-FES的合成方法和质量控制要求, 给出其临床应用场景的推荐, 并进行分级。此外, 从显像 前准备、显像流程、图像分析（正常生物分布、ER阳性和阴性的判定、病灶部位、影响因素、假阴性和假阳性、报告书 写）等全流程系统、详尽给出了专家建议, 指出了该显像技术的局限性, 并对未来应用前景予以展望。该技术标准的制定 旨在推动 18 F-FES PET技术在国内的规范化应用, 实现报告解读一致、结果互认、指标可比, 为乳腺癌精准诊疗提供重要的 分子影像技术支撑. [ABSTRACT FROM AUTHOR]

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