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.

项目摘要： 肺癌是全球最具侵略性和最常见的恶性肿瘤之一。而手术切除仍然是 治愈的最佳机会，只有20％的患者有资格接受手术。其余患者通过组合进行管理 放疗和化学疗法以及最近的侵入性立体定向放射疗法和经皮疗法较少 热消融。经射频消融（RFA）或微波炉消融是具有成本效益的治疗方法 无法切除的肿瘤的选择。这种微创方法，尽管有效地治疗了某些阶段1和 2单独或与其他疗法结合使用的非小细胞肺癌在其能力方面受苦 在没有危险的不良事件（例如气胸）的情况下创建有足够边缘的肿瘤的热破坏 和附带伤害。 该提案的目的是完善与与该系统兼容的全长的，支气管RFA系统的设计 支气管镜的工作通道，可以实现直径为2-3 cm的外周结节的热消融 气胸的最小风险。我们创新的方法克服了过去使用RFA制造大病变的尝试 不通过在单个设备中合并空气吸气和灌溉流以增加病变的情况下越过气道 使用自定义RF发电机算法。我们的设备旨在与目前可用于肺部肿瘤的工具一起使用 活检或成像（例如径向EBU），也可以与当代导航和机器人一起使用 系统。 该项目将在几个顺序阶段完成。对于此阶段II 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。本赠款中获得的信息将直接用于指导 EFS-IDS向FDA提交，作为赠款未来阶段的一部分。