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自动生成放射性追踪剂[¹⁸F]FZTA用于对人类的基-1-受体1 (S1PR1) 的成像

Lin Qiu¹, Christopher Bognar¹, Vijai Kumar Reddy Tangadanchu¹

¹Department of Radiology, Washington University School of Medicine, Saint Louis, Missouri, 63110, United States.

Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine

|August 30, 2025

概括

一种新的自动化方法可靠地产生[18F]FZTA,这是一个有前途的PET标记剂,用于基-1-受体1 (S1PR1). 这种符合cGMP的工艺产生了适用于人体研究的高纯度标记剂.

科学领域:

放射化学
核医学
药理学

背景情况:

素-1-受体1 (S1PR1) 是各种疾病的关键点.
在体内S1PR1成像中,开发特定的PET配体至关重要.
现有的PET标记剂在产量或纯度上可能存在限制.

研究的目的:

开发和验证一种可靠的自动放射合成新型F-18标记S1PR1PET连接体,FZTA.
确保辐射追踪器符合潜在人类使用的cGMP标准.
评估[18F]FZTA用于探索性新药 (IND) 应用的可行性.

主要方法:

使用GE TRACERlab FX2N模块对[18F]FZTA进行自动放射合成.
通过半准备性HPLC进行[18F]化,去除保护和净化.
质量控制包括放射化学产量,纯度和活动的确定.
验证运行以确保可重复性和遵守cGMP.

主要成果:

在约60分钟内成功放射合成[18F]FZTA.
放射性化学产量为13.9 ± 2.9%,放射性化学纯度为> 91%,摩尔活性为> 147 GBq/μmol (腐蚀纠正).
连续三次验证证实产品质量符合所有规格.

结论:

开发的自动化程序提供了一种可靠的方法来生产S1PR1 PET配体[18F]FZTA.
无线电追踪器符合潜在临床应用的严格质量控制标准.
[18F]FZTA作为人类S1PR1的PET成像剂具有前景.

关键词:

自动化放射合成 -18 的阳离子辐射断层扫描斯芬戈辛-1-酸盐受体1 [(18) F]FZTA 地区 cGMP 公司

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