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用PET/CT进行功能性肝脏成像的化学前体TEoS-DAZA的毒性研究

Julia Greiser¹, Beatrice Engert², Roman Föll³

¹Nuclear Medicine Department, Jena University Hospital, Am Klinikum 1, 07747, Jena, Germany.

EJNMMI radiopharmacy and chemistry

|May 17, 2025

概括

在大鼠中进行的N,1,4-Tri(4-乙氧-2-基) -1,4-亚泽潘-6-胺 (TEoS-DAZA) 毒性研究表明,即使在高剂量中,也没有任何不良影响. 这种肝脏特异性的放射性药物前体对于人类临床使用是安全的.

科学领域:

放射性药物开发的发展.
在临床前的毒理学.
诊断成像剂诊断成像剂

背景情况:

N,1,4-Tri(4-乙氧-2-基) -1,4-亚泽-6-胺 (TEoS-DAZA) 是肝脏特异性Ga基放射性药物的新型前体.
在大鼠中进行了临床前毒性测试,以确保人类临床研究的安全性.

研究的目的:

根据监管指南,评估TEoS-DAZA在Wistar大鼠中的毒性.
在人类临床试验之前确定TEoS-DAZA的安全性.

主要方法:

在老鼠中,TEoS-DAZA在三种剂量水平的静脉注射.
24小时观察和14天的恢复期用于毒性评估.
综合性监测包括临床症状,体重,功能测试,血液学,临床生物化学,尸体解剖和组织病理学.

主要成果:

在任何剂量水平上都没有观察到与试验物品相关的不良反应.
在康复期后,没有发现延迟的不良影响.
对于TEOS-DAZA,没有观察到的不良反应水平 (NOAEL) 确定为1.4mg/kg体重.

结论:

在老鼠中,一千倍的TEoS-DAZA临床剂量没有诱导可观察到的不良事件.
[⁶⁸Ga]Ga-TEoS-DAZA (100微克前体) 的注射溶液在药理上对人类临床应用是安全的.
需要进一步的剂量测量研究来评估与辐射相关的毒性.

关键词:

化学前体的化学前体肝胆皮质片 (PET) 是一种肝胆皮质片.国际货币基金组织M3 (R2)微剂量微剂量微剂量临床前毒理学研究放射性药物放射性药物是一种放射性药物.这就是TEOS-DAZAZA.

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