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.

项目总结/摘要 该SBIR第一阶段应用旨在研究一种新的术中反馈 用于局部热治疗的微波消融（MWA）手术的机制 癌虽然MWA提供了一种微创、低成本的门诊治疗， 结果与金标准手术切除小肿瘤、局部复发 对于大肿瘤（直径> 3cm），比率仍然相当高。热剂量不足 递送到靶向肿瘤并且不能建立足够的治疗边界 是热消融术复发率较高的主要原因。虽然对比度增强 X射线CT成像提供了一种用于验证术后消融体积的方法， 没有用于监测消融区并在消融期间提供可操作信息的技术 程序不完全消融可能导致疾病复发， 重新执行程序，加重患者和医院的负担，其中CT套件是一个 资源容量受限。或者，过量的热剂量可能会无意中伤害 附近的健康组织，并需要额外的医疗干预。利用独特的功能 在我们团队先前开发的专利定向MWA（DMWA）施用器中，我们发现 一种新的方法，使用我们的施源器来提供治疗，并作为传感器来跟踪 状态并估计真实的MWA程序的完成情况。这项创新提供了 临床医生的关键术中反馈，并给予信心，他们取得了结果， 想要并且没有过度治疗或治疗不足，同时还保留了靶器官的完整性， 从而减少对其他敏感组织的附带损伤的机会。这项创新并不需要 当前临床工作流程的重大变更或排除继续使用消融后 确认成像。R43 SBIR第一阶段应用的总体目标是显示 我们提出的反馈方法的技术概念证明。我们第一个具体的 目的包括开发一个预测性的电磁-传热耦合物理模型， 我们的反馈系统使用有限元方法软件工具。然后我们将构建一个 实验装置，以监测和记录在我们的电磁参数 反馈系统，并进行体外实验台实验，以证明概念和 完善我们的计算机模型我们的第二个具体目标包括与 我们的兽医学校评估我们的反馈系统在临床环境中使用后程序 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 扩大患者获得微创，负担得起的癌症门诊治疗的机会。