Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation

项目总结： 肺癌是世界上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 最好的治愈机会，只有20%的患者有资格接受手术。其余患者采用组合管理。 放射治疗和化疗，以及最近侵入性较小的立体定向放射治疗和经皮 热消融。经皮射频消融(RFA)或微波消融是经济有效的治疗方法 不能切除的肿瘤的选择。这种微创方法虽然对某些分期为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，其治疗能力都受到影响。 在没有气胸等严重不良事件的情况下，对肿瘤进行有足够边缘的热破坏 以及附带伤害。 这项提议的目标是完善全长、支气管腔内RFA系统的设计，使其与 支气管镜工作通道，可实现对直径2-3厘米周围结节的热消融 气胸的风险最小。我们的创新方法克服了过去使用RFA进行大损伤的尝试 无需通过在单个设备中组合吸气和冲洗流量来共同增加病变而穿过呼吸道 使用定制的射频生成器算法。我们的设备旨在与目前可用的治疗肺部肿瘤的工具一起使用 活组织检查或成像(例如放射状EBUS)，也可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。对于此第二阶段SBIR，我们将优化和完善我们的 RFA的创新方法，开发具有验证和验证测试的临床级别系统，并演示 临床前研究中的安全性和可控性。在这项资助中获得的信息将直接用于指导 EFS-IDE向FDA提交，作为赠款未来阶段的一部分。

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.