Radioactive Stents for Brachytherapy of Esophageal Cancers

 描述(由申请人提供)： 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。研究人员已经证明了一种先进的放射性食道支架的可行性，这种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益处。支架制造商、外科专家、领先的剂量学家和监管专业人员之间已经建立了更广泛的合作，以开发放射性食道支架。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)放射性食道支架的装置安全性论证；(2)获得FDA的510(K)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 demonstrated the feasibility of an 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. A broader collaboration has been established among stent manufacturer, surgical experts, leading dosimetrist, and regulatory professionals for the development of radioactive esophageal stents. The ultimate goal is to improve treatment efficacy by matching radiation dose distribution to tumor distribution. The specific aims include (1) device safety demonstration of radioactive esophageal stents; (2) obtaining 510(k) FDA clearance. The Phase II research will begin with in vivo biocompatibility assessment and end with preliminary clinical assessment using the proposed advanced radioactive esophageal stents.