Novel Minimally Invasive Endobronchial Approach for Lung Cancer Ablation

肺癌消融的新型微创支气管内方法

基本信息

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
项目类别：
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

项目摘要

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。