Boron neutron capture therapy (BNCT) involves infusion of cancer patients with a tumor-seeking, boron-loaded compound and irradiation by a beam of neutrons, with an energy range of 1 eV-10 keV. Neutron capture in the 10B atoms results in an effective lethal radiation dose to the tumor cells, while sparing the healthy tissue. Recently available accelerator-based irradiation facilities facilitate developing BNCT to a treatment modality. However, the binary principle of BNCT, together with other points, is challenging in designing clinical trials that allow a timely and safe introduction of this innovative targeted modality into clinical practice. We propose a methodological framework to work toward a systematic, coordinated, and internationally accepted and evidence-based approach.

中文翻译：

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硼中子俘获疗法的战略性临床试验设计。

硼中子俘获疗法 (BNCT) 涉及向癌症患者输注一种寻找肿瘤的载硼化合物，并用能量范围为 1 eV-10 keV 的中子束进行照射。10B 原子中的中子俘获会对肿瘤细胞产生有效的致死辐射剂量，同时保护健康组织。最近可用的基于加速器的辐照设施有助于将 BNCT 开发为治疗方式。然而，BNCT 的二元原则以及其他要点在设计临床试验时具有挑战性，这些临床试验允许及时、安全地将这种创新的靶向方式引入临床实践。我们提出了一个方法论框架，以朝着系统、协调、国际认可和基于证据的方法努力。