MWA verification system for improved confidence in treatment outcomes

项目摘要/摘要 此SBIR第一阶段应用程序旨在研究一种新的程序内反馈 微波消融(MWA)用于局部热治疗的机理 癌症。尽管MWA提供了一种微创、低成本的门诊治疗方法， 小肿瘤、局部复发的金标准手术切除的结果类似 大肿瘤(直径3厘米)的发病率仍然相当高。热剂量不足 向靶向肿瘤的递送和未能建立足够的治疗余量被认为 是热消融复发率较高的主要原因。虽然增强了对比度 X射线CT成像提供了一种验证术后消融体积的方法，在那里 没有监测消融区和提供可操作信息的技术 手术过程。不完全消融可能会导致疾病复发并有必要 重新执行程序，加重患者和CT套件所在医院的负担 容量受限的资源。或者，过量的热剂量可能会在不经意间伤害 接近健康组织，需要额外的医疗干预。利用独特的功能 在我们团队之前开发的专利定向MWA(DMWA)喷涂器中，我们识别了 一种新的方法，它使用我们的敷贴器来提供治疗和充当传感器来跟踪 实时评估MWA程序的完成情况。这一创新提供了 临床医生提供关键的程序内反馈，并对他们取得的结果充满信心 想要的而不是过度或不足的治疗，同时也保持目标器官和 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 对当前临床工作流程的重大改变或阻止继续使用消融后 确认成像。此R43 SBIR第一阶段应用的总体目标是展示 我们建议的反馈方法的概念的技术证明。我们的第一个具体方法是 AIM包括开发一种预测电磁-热耦合物理模型 我们的反馈系统采用有限元软件工具。然后，我们将构建一个 用来监测和记录我们所使用的电磁参数的实验装置 反馈系统，并进行体外台式实验，以显示概念验证和 完善我们的计算机模型。我们的第二个具体目标包括与 我们的兽医学校在临床环境中使用手术后评估我们的反馈系统 CT影像和组织病理学检查。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。

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.