Radioactive Stents for Brachytherapy of Esophageal Cancers

描述（由申请方提供）：美国目前对无法手术的食管癌的实践是使用金属支架对终末期癌症患者进行姑息治疗。在美国以外（特别是在包括中国和韩国在内的远东国家），已经报告了将密封源（如前列腺粒子）连接到食管支架外部的临床受益。虽然简单和初步的，这种放射性同位素来源增加了一倍的平均生存期，具有很高的统计学置信度。研究人员分析了当前的最新技术水平，并形成了一个关键的跨学科专家集群，用于开发先进的放射性食管支架，该支架将最大限度地增加肿瘤剂量，并显着缩短剂量输送时间，以更快地实现最大化的临床效益。第一阶段的研究重点是放射性同位素的治疗能量和放射性同位素源与流行支架的整合。最终目标是通过使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）确定与最佳食管支架集成的最佳放射性同位素来源;（2）保留器械分类为510 K，以便更快获得FDA批准。II期研究将从体内生物相容性评估开始开始，并以使用申报的高级放射性食管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.