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神经肿瘤学中诊疗一体化试验的设计与开展:挑战与机遇

Design and conduct of theranostic trials in neuro-oncology: Challenges and opportunities.

作者信息

Wen Patrick Y, Preusser Matthias, Albert Nathalie L

机构信息

Center For Neuro-Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, USA.

Department of Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria.

出版信息

Neuro Oncol. 2024 Dec 9;26(Supplement_9):S199-S207. doi: 10.1093/neuonc/noae162.

DOI:10.1093/neuonc/noae162
PMID:39368109
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11631090/
Abstract

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, optimize 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.

摘要

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型治疗模式。治疗诊断剂已获得某些全身性癌症的监管批准,并且在神经肿瘤学中具有治疗潜力。随着评估治疗诊断剂在脑肿瘤中疗效的临床试验的开展,必须考虑一些特定因素,同时要借鉴以往在神经肿瘤学中研究其他治疗模式所汲取的经验教训。这些因素包括需要进行分子成像或手术时机研究,以确认药物能够充分通过血脑屏障、优化入选标准,以及选择最合适的反应标准和终点来解决诸如假性进展等问题。本综述将讨论在设计治疗诊断剂临床试验时应考虑的一些问题。

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