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Updated: Feb 18, 2026

An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use

An Automated Radiosynthesis of [⁶⁸Ga]Ga-FAPI-46 for Routine Clinical Use

Published on: May 24, 2024

[作为PRECISION临床试验的一部分,实施68Ga-FAPI-46标签.]

Noémie Allouche¹, Amélie Coussirou¹, David Tonnelet¹

¹Médecine nucléaire, centre Henri Becquerel, Rouen, France.

Annales pharmaceutiques francaises

|February 16, 2026

概括

经过验证的[68Ga]Ga-FAPI-46 PET成像生产用于三阴性乳腺癌临床试验. 这种方法使得在PRECISION试验中能够提交高级癌症成像的监管申请.

科学领域:

核医学就是核医学.
放射性药物化学放射性药物化学
在瘤学瘤学.

背景情况:

三阴性乳腺癌 (TNBC) 缺乏有效的成像生物标志物.
纤维细胞激活蛋白 (FAP) 在TNBC瘤中过度表达,使其成为有前途的成像标.
[18F]FDG PET对TNBC成像具有局限性.

研究的目的:

为了验证[68Ga]Ga-FAPI-46.6的自动化放射合成方法.
为了支持PRECISION临床试验的监管提交,该试验评估了TNBC中的[68Ga]Ga-FAPI-46 PET.
评估[68Ga]Ga-FAPI-46作为新辅助化学免疫治疗反应的预测生物标志物.

主要方法:

使用Trasis Mini AIO系统和GalliaPharm发电机进行[68Ga]Ga-FAPI-46的自动放射合成.
通过固态提取和终端杀菌过的净化.
严格的质量控制,包括放射性化学纯度 (HPLC,TLC),稳定性和根据欧洲药典标准进行微生物学测试.

主要成果:

在七个合成中成功验证了自动化放射合成方法.
分析方法证实符合验证标准 (精度,稳定性,线性).
三批验证批量符合所有释放标准,证明了方法的可靠性.

结论:

[68Ga]Ga-FAPI-46的自动放射合成已经得到验证并可靠.
这种经过验证的方法有助于向ANSM提交共同技术文件 (CTD),以便在临床试验中使用.
[68Ga]Ga-FAPI-46 PET成像显示了预测TNBC治疗反应的潜力.

关键词:

乳腺癌是什么? 乳腺癌是什么?乳腺癌是因为乳腺癌.在FAPI-46中使用.在这里,PET是PET.无线电药房无线电药房无线电药房放射性药房是一个放射性药房.这就是TEPEP.试验药物研究中的药物.试验性药物试验性药物

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