治疗诊断学是一种将分子成像与靶向放射性核素治疗相结合的新治疗方式。治疗诊断剂已获得监管部门批准用于治疗某些系统性癌症，并且在神经肿瘤学方面具有治疗潜力。随着临床试验的开展是为了评估治疗诊断药物对脑肿瘤的疗效，必须考虑具体的考虑因素，同时考虑到以前研究神经肿瘤学其他治疗方式的研究中吸取的经验教训。其中包括需要进行分子成像或手术机会窗口研究，以确认是否有足够的机会穿过血脑屏障、优化资格标准以及选择最合适的反应标准和终点来解决假性进展等问题。本综述将讨论设计治疗诊断药物临床试验时应考虑的一些问题。© 作者 2024。由牛津大学出版社代表神经肿瘤学会出版。版权所有。如需商业重复使用，请联系 reprints@oup.com 获取转载和转载的翻译权。所有其他权限都可以通过我们网站文章页面上的权限链接通过我们的 RightsLink 服务获得 - 如需了解更多信息，请联系journals.permissions@oup.com。

Theranostics is a new treatment modality integrating molecular imaging with targeted radionuclide therapy. Theranostic agents have received regulatory approval for some systemic cancers and have therapeutic potential in neuro-oncology. As clinical trials are developed to evaluate the efficacy of theranostic agents in brain tumors, specific considerations will have to be considered, taking into account lessons learned from previous studies examining other treatment modalities in neuro-oncology. These include the need for molecular imaging or surgical window-of-opportunity studies to confirm adequate passage across the blood-brain barrier, optimizing eligibility criteria and selection of the most appropriate response criteria and endpoints to address issues such as pseudoprogression. This review will discuss some of the issues that should be considered when designing clinical trials for theranostic agents.© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.