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.

项目概要/摘要 该 SBIR 第一阶段应用旨在研究一种新颖的程序内反馈 用于局部热处理的微波消融 (MWA) 程序机制 癌症。尽管 MWA 提供了一种微创、低成本的门诊治疗方法， 与小肿瘤、局部复发的金标准手术切除结果相当 大肿瘤（直径 > 3 厘米）的发生率仍然相当高。热剂量不足 据信递送至目标肿瘤且未能建立足够的治疗裕度 是热消融复发率较高的主要原因。虽然对比度增强 X 射线 CT 成像提供了一种在手术后验证消融体积的方法， 没有技术可以监测消融区域并在消融过程中提供可操作的信息 程序。不完全消融可能导致疾病复发并需要 重新进行手术，给患者和使用 CT 套件的医院带来负担 资源容量有限。另外，过多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。利用独特的能力 我们团队之前开发的获得专利的定向 MWA (DMWA) 涂抹器，我们确定 一种新方法，使用我们的涂抹器进行治疗并充当传感器进行跟踪 实时评估 MWA 程序的状态和完成情况。这项创新提供了 临床医生对程序内反馈提出批评，并相信他们取得了预期的结果 想要并且没有过度或治疗不足，同时还保留了目标器官的完整性和 减少对其他敏感组织造成附带伤害的机会。这项创新不需要 当前临床工作流程的重大变化或阻止继续使用消融后 确认成像。 R43 SBIR 第一阶段应用的总体目标是展示 我们提出的反馈方法的概念技术证明。我们第一个具体的方法 目标包括开发预测耦合电磁传热物理模型 我们的反馈系统使用有限元法软件工具。然后我们将构造一个 监测和记录我们的电磁参数的实验装置 反馈系统并进行离体台式实验以展示概念验证和 完善我们的计算机模型。我们的第二个具体目标包括与以下机构合作进行体内研究 我们的兽医学校在临床环境中使用术后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 扩大患者获得微创、负担得起的门诊癌症治疗的机会。