Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation

肺癌消融的新型微创支气管内方法

• 批准号: 10249490
• 负责人: Howard Levin
• 金额: $ 78.39万
• 依托单位: CORIDEA, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10249490
• 关键词: 3-Dimensional; Ablation; Acute; Air; Algorithms; Animal Model; Animals; Autopsy; Biopsy; Bronchoscopes; Caliber; Cancerous; Catheters; Cells; Chronic; Clinical; Clinical Pathology; Clinical Trials; Computer software; Contracts; Coughing; Custom; Data; Development; Devices; Diagnosis; Dimensions; Disease; Distal; Dose; Engineering; Ensure; Excision; Feasibility Studies; Fibrosis; Fistula; Future; Goals; Grant; Health; Hemorrhage; Histopathology; Human; Image; Incineration; Infection; Injury; Investigation; Irrigation; Length; Lesion; Life; Lobectomy; Lung; Lung Neoplasms; Malignant Neoplasms; Malignant neoplasm of lung; Medical; Methods; Navigation System; Nodule; Non-Small-Cell Lung Carcinoma; Operative Surgical Procedures; Pathology; Patients; Periodicity; Peripheral; Phase; Physicians; Pleura; Pneumothorax; Positioning Attribute; Preparation; Production; Radial; Radiation therapy; Radiofrequency Interstitial Ablation; Risk; Running; Safety; Serious Adverse Event; Small Business Innovation Research Grant; Stains; Structure; System; Techniques; Temperature; Testing; Therapeutic; Thermal Ablation Therapy; Time; Tissues; Tube; Unresectable; Validation; Work; base; behavior observation; chemotherapy; clinical effect; cost; cost effective treatment; design; effective therapy; electric impedance; experimental study; flexibility; healing; hemodynamics; innovation; instrument; irritation; lung lobe; lung preservation; meetings; microwave ablation; minimal risk; minimally invasive; novel; novel therapeutics; porcine model; pre-clinical; preclinical safety; preclinical study; programs; prototype; pulmonary function; rate of change; research and development; respiratory; response; robotic system; safety and feasibility; safety testing; tool; tumor; tumor ablation; verification and validation

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.

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 治愈的机会最大，只有20%的患者适合手术。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治疗 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。这种微创方法虽然对某些 1 期和 2 非小细胞肺癌无论是单独治疗还是与其他治疗联合治疗，都会受到其治疗能力的影响 对具有足够边缘的肿瘤进行热破坏，而不会产生气胸等严重不良事件的风险 和附带伤害。 该提案的目标是完善全长支气管内 RFA 系统的设计，该系统与 支气管镜工作通道，可实现直径2-3cm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 制造大病灶的尝试 通过在单个设备中结合空气抽吸和冲洗流来增加病变，无需穿过气道 使用定制的射频发生器算法。我们的设备设计用于与当前可用的肺部肿瘤工具一起使用 活检或成像（例如，径向 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系统，并证明 临床前研究的安全性和可控性。本次赠款中获得的信息将直接用于指导 作为未来阶段拨款的一部分，向 FDA 提交 EFS-IDE 申请。