Radioactive Stents for Brachytherapy of Esophageal Cancers

 描述（由申请人提供）： 美国目前对无法手术的食管癌的治疗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。研究人员已经证明了先进的放射性食管支架的可行性，该支架将最大限度地增加肿瘤的剂量，并显着缩短剂量输送时间，以更快地实现最大的临床效益。在支架制造商、外科专家、主要剂量测定师和监管专业人员之间建立了更广泛的合作，以开发放射性食管支架。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。具体目的包括（1）放射性食管支架的器械安全性证明;（2）获得510（k）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 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.