Radioactive Stents for Brachytherapy of Esophageal Cancers

描述(申请人提供)：美国目前对不能手术的食道癌的治疗方法是对终末期癌症患者使用金属支架进行姑息治疗。在美国以外(特别是在远东国家，包括中国和韩国)，已经有报道称，将前列腺籽等密封来源附着在食道支架的外部具有临床益处。虽然简单和初步，但这种放射性同位素来源在统计上具有很高的可信度，使平均存活期翻了一番。研究人员分析了目前最先进的技术，并形成了一个关键的跨学科专家集群，以开发先进的放射性食道支架，该支架将最大限度地增加对肿瘤的剂量，并显著缩短剂量传递时间，以更快地实现最大的临床效益。第一阶段的研究重点是放射性同位素的治疗能量以及放射性同位素来源与常用支架的整合。最终目标是通过将辐射剂量分布与肿瘤分布相匹配来提高治疗效果。具体目标包括(1)确定与最好的食道支架集成的最佳放射性同位素来源；(2)将设备分类保留为510K，以便更快地获得FDA的批准。第二阶段的研究将从体内生物相容性评估开始，以使用拟议的先进放射性食道支架进行初步临床评估结束。

DESCRIPTION (provided by applicant): Current practice in the USA for inoperable esophageal cancer is a palliative treatment using metal stent for end-stage cancer patients. Outside the USA (especially in Far East countries including China and Korea), there have been reported clinical benefits of attaching sealed sources such as prostate seeds to the outside of an esophageal stent. Although simple and preliminary, such radioisotope sources had doubled the mean survival period with high statistical confidence. The investigators have analyzed the current state-of-the-art and have formed a critical cluster of interdisciplinary experts for the development of advanced radioactive esophageal stents that will maximize dose to the tumors and significantly shorten the dose delivery time to more quickly achieve maximized clinical benefits. The Phase I research focuses on the therapeutic energy of radioisotopes and the integration of radioisotope sources with popular stents. The ultimate goal is to improve treatment efficacy by matching radiation dose distribution to tumor distribution. The specific aims include (1) identifying the best radioisotope sources for integration with the best esophageal stents; (2) preserving the device classification as 510K for faster FDA approval. The Phase II research will begin with in vivo biocompatibility assessment and end with preliminary clinical assessment using the proposed advanced radioactive esophageal stents.