Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation

项目概要： 肺癌是世界范围内最具侵袭性和最常见的恶性肿瘤之一。虽然手术切除仍然是 虽然治愈率最高，但只有20%的患者有资格接受手术。其余患者采用联合治疗 放疗和化疗，以及最近的微创立体定向放疗和经皮 热消融经皮射频消融（RFA）或微波消融是具有成本效益的治疗方法 不可切除肿瘤的选择。这种微创方法，虽然有效的治疗一些阶段1和 2非小细胞肺癌无论是单独治疗还是与其他疗法联合治疗， 产生足够边缘的肿瘤热破坏，而不会发生气胸等严重不良事件 和附带伤害 本提案的目标是完善与以下器械兼容的全长支气管内RFA系统的设计： 支气管镜的工作通道，可以实现直径2-3 cm的外周结节的热消融， 气胸的风险很小我们的创新方法克服了过去使用RFA制造大病变的尝试 而不通过在单个装置中组合空气抽吸和冲洗流以一起增加损伤而穿过气道 用定制的射频发生器算法我们的设备设计用于与目前可用的工具一起用于肺部肿瘤 活组织检查或成像（例如，径向EBUS），也可以与现代导航和机器人结合使用 系统. 该项目将分几个连续阶段完成。对于第二阶段SBIR，我们将优化和完善我们的 射频消融的创新方法，开发具有验证和确认测试的临床级系统，并证明 临床前研究的安全性和可控性。在此赠款中获得的信息将直接用于指导 EFS-IDE提交给FDA，作为未来阶段拨款的一部分。

PROJECT SUMMARY: Lung cancer is one of the most aggressive and common malignancies world-wide. While surgical resection remains the best chance of cure, only 20% of patients are eligible for surgery. The remaining patients are managed with combinations of radiotherapy and chemotherapy and more recently with less invasive stereotactic radiotherapy and percutaneous thermal ablation. Percutaneous radio-frequency ablation (RFA) or microwave ablation are cost-effective treatment options for unresectable tumors. This minimally invasive approach, though effective for treatment of some stage 1 and 2 non-small cell lung carcinomas either alone or in combination with other therapies, suffer in terms of their ability to create thermal destruction of the tumors with sufficient margin without risking serious adverse events like pneumothorax and collateral injury. The goal of this proposal is to refine the design of a full-length, endobronchial RFA system that is compatible with the working channel of a bronchoscope and can achieve thermal ablation of peripheral nodules 2-3 cm in diameter with minimal risk of pneumothorax. Our innovative approach overcomes past attempts of using RFA to make large lesions without crossing the airway by combining, in a single device, air aspiration and irrigation flow to increase lesion together with a custom RF generator algorithm. Our device is designed to be used with currently available tools for lung tumor biopsy or imaging (e.g., radial EBUS) and can also be used in conjunction with contemporary navigation and robotic systems. This project will be completed in several sequential stages. For this Phase II SBIR we will optimize and refine our innovative approach to RFA, develop a clinical-grade system with verification and validation tests, and demonstrate safety and controllability in preclinical studies. The information obtained in this grant will be used directly to guide EFS-IDE submission with the FDA as part of a future phase of the grant.