MWA verification system for improved confidence in treatment outcomes

MWA 验证系统可提高治疗结果的信心

• 批准号: 10481747
• 负责人: Austin Pfannenstiel
• 金额: $ 40万
• 依托单位: PRECISION MICROWAVE, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10481747
• 关键词: Ablation; Ambulatory Care; Animals; Caliber; Cancer Patient; Clinical; Collaborations; Computer Models; Coupled; Dependence; Development; Disease; Dose; Effectiveness; Electromagnetics; Elements; Equilibrium; Evolution; Excision; Failure; Family suidae; Feedback; Goals; Gold; Heating; Histopathology; Hospitals; Image; Image Enhancement; Injury; Intervention; Kidney; Lead; Legal patent; Literature; Liver; Localized Malignant Neoplasm; Lung; Measures; Medical; Methods; Modeling; Monitor; Normal tissue morphology; Operative Surgical Procedures; Organ; Outcome; Outpatients; Patients; Pattern; Phase; Physicians; Physics; Positioning Attribute; Procedures; Real-Time Systems; Recurrence; Research; Resources; Safety; Slice; Small Business Innovation Research Grant; Software Tools; System; Techniques; Thermal Ablation Therapy; Time; Tissues; Treatment outcome; Veterinary Schools; Visual; X-Ray Computed Tomography; base; cancer therapy; contrast enhanced; contrast enhanced computed tomography; cost; dielectric property; experience; experimental study; image guided; improved; in vivo; innovation; microwave ablation; microwave electromagnetic radiation; minimally invasive; novel; overtreatment; physical state; preservation; sensor; skills; success; transmission process; tumor; tumor progression; ultrasound

PROJECT SUMMARY/ABSTRACT This SBIR Phase I application aims to investigate a novel intra-procedural feedback mechanism for microwave ablation (MWA) procedures used for the thermal treatment of localized cancer. Although MWA provides a minimally invasive, low cost, outpatient therapy that has comparable outcomes to the gold standard surgical resection for small tumors, local recurrence rates remain considerably higher for large tumors (> 3 cm diameter). Inadequate thermal dose delivery to the targeted tumor and failure to establish an adequate treatment margin is believed to be a primary cause of thermal ablation’s higher recurrence rates. While contrast-enhanced imaging with X-ray CT provides a means for verifying the ablation volume post-procedure, there are no techniques for monitoring the ablation zone and providing actionable information during the procedure. Incomplete ablation could result in disease recurrence and necessitate reperformance of the procedure, burdening patients and hospitals where the CT-suite is a capacity constrained resource. Alternatively, excessive thermal dose could inadvertently injure nearby healthy tissues and require additional medical intervention. Leveraging unique capabilities of the patented directional MWA (DMWA) applicator our team previously developed, we identified a new method which uses our applicators to both deliver treatment and act as sensors to track the status and estimate the completion of MWA procedures in real time. This innovation provides clinicians critical intra-procedural feedback and give confidence that they achieved the result they wanted and did not over- or under-treat while also preserving the integrity of the target organ and reducing the chance of collateral injury to other sensitive tissues. This innovation does not require significant changes to current clinical workflow or preclude continued use of post-ablation confirmation imaging. The overall objective of this R43 SBIR Phase I application is to show technical proof of concept for our proposed feedback method. The approach for our first specific aim includes development of a predictive coupled electromagnetic-heat transfer physics model of our feedback system using finite element method software tools. We will then construct an experimental apparatus to monitor and record the electromagnetic parameters utilized in our feedback system and conduct ex vivo benchtop experimentation to show proof-of-concept and refine our computer model. Our second specific aim includes an in vivo study in collaboration with our veterinary school to evaluate our feedback system in a clinical setting using post-procedure CT imaging and histopathology. Our long-term goal is to improve safety and effectiveness of MWA to expand patient access to minimally invasive, affordable, outpatient treatment of cancer.

项目摘要/摘要 SBIR I期应用程序旨在调查新型的心理内反馈 用于局部热处理的微波消融机制（MWA）程序 癌症。尽管MWA提供了一种微创，低成本，门诊疗法 与小肿瘤的金标准手术切除术的可比较结局，局部复发 大肿瘤的速率保持适当较高（直径> 3 cm）。热剂量不足 据信，递送到靶向肿瘤并无法建立足够的治疗余量 成为热消融较高复发率的主要原因。虽然对比增强 使用X射线CT进行成像提供了一种用于验证后处理的消融体积的手段， 没有用于监视消融区并提供可行信息的技术 过程。不完整的消融可能导致疾病复发和必要 该手术的重复性，燃烧的患者和医院是CT-Suite是一个 容量限制了资源。在线，过量的热剂量可能会无意中伤害 附近的健康组织，需要额外的医疗干预。利用独特的功能 我们的团队先前开发的专利定向MWA（DMWA）施用器，我们确定了 一种新方法，它使用我们的涂抹者提供治疗并充当传感器以跟踪 状态和估算实时完成MWA程序的完成。这项创新提供了 临床医生批判性心脏内部反馈，并确信他们取得了成果 想要和不及格的通缉或不及格，同时也保留了目标器官的完整性和 减少了对其他敏感组织的附带损伤的机会。这项创新不需要 当前的临床工作流程或排除启动后继续使用的重大变化 确认成像。此R43 SBIR I期应用程序的总体目标是显示 我们提出的反馈方法的技术概念证明。我们第一个特定的方法 目的包括开发预测耦合的电磁热传递物理模型 我们使用有限元方法软件工具的反馈系统。然后，我们将构建一个 实验设备以监视和记录我们中使用的电子参数 反馈系统并进行离体台式实验，以显示概念证明和 完善我们的计算机型号。我们的第二个具体目的包括与 我们的兽医学校使用后处理，在临床环境中评估我们的反馈系统 CT成像和组织病理学。我们的长期目标是提高MWA的安全性和有效性 为了扩大患者的最低侵入性，负担得起的门诊治疗癌症的机会。