Common challenges and problems in clinical trials of boron neutron capture therapy of brain tumors

Common challenges and problems in clinical trials of boron neutron capture therapy of brain tumors
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硼中子俘获治疗脑肿瘤临床试验中的常见挑战和问题

DOI:
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发表时间:
2003
影响因子:
3.9
通讯作者:
B. Albertson
B. Albertson
中科院分区:
医学2区
文献类型:
--
作者:
Namit Gupta;R. Gahbauer;T. Blue;B. Albertson

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二元疗法的临床试验,如硼中子俘获疗法(BNCT),在设计、性能和结果解释方面提出了许多独特的问题和挑战。在中子束开发中,不同的小组使用不同的优化参数,导致束彼此之间存在很大差异。患者药代动力学的设计、开发、检测和执行以及这些研究结果的评价存在很大差异。最后,涉及患者治疗的临床试验在许多方面有所不同,例如其剂量递增策略,治疗计划方法和数据报告。这些差异的影响,从这些试验中积累的数据进行了讨论。BNCT社区需要标准化临床试验的设计、实施和报告的各个方面,以便有意义地使用数据。
SummaryClinical trials for binary therapies, like boron neutron capture therapy (BNCT), pose a number of unique problems and challenges in design, performance, and interpretation of results. In neutron beam development, different groups use different optimization parameters, resulting in beams being considerably different from each other. The design, development, testing, execution of patient pharmacokinetics and the evaluation of results from these studies differ widely. Finally, the clinical trials involving patient treatments vary in many aspects such as their dose escalation strategies, treatment planning methodologies, and the reporting of data. The implications of these differences in the data accrued from these trials are discussed. The BNCT community needs to standardize each aspect of the design, implementation, and reporting of clinical trials so that the data can be used meaningfully.
开发和建造用于基于加速器的硼中子俘获滑膜切除术的中子束线。
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