In vivo feasibility of a smart needle ablation treatment for liver cancer

智能针消融治疗肝癌的体内可行性

基本信息

批准号：
10699190
负责人：
Alireza Mashal
金额：
$ 40万
依托单位：
CURRENT SURGICAL INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-01 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10699190
关键词：
Ablation Acoustics Address Adult Affect Algorithms Anatomy Animals Arteries Atrial Fibrillation Breast Cardiac ablation Childhood Cryosurgery Data Databases Detection Development Devices Disease Epilepsy Family suidae Feedback Focused Ultrasound Therapy Goals Incidence Intervention Kidney Left Liver Liver neoplasms Location Lung Malignant Neoplasms Malignant neoplasm of liver Marketing Methods Modeling Needles Neurologic Newly Diagnosed Operative Surgical Procedures Patient risk Patients Performance Perfusion Phase Physics Pilot Projects Population Positioning Attribute Procedures Property Recurrent tumor Regulatory Pathway Resolution Screening for Hepatocellular Cancer Shapes Site Small Business Innovation Research Grant Solid Neoplasm Structure Surgeon Survival Rate Techniques Technology Testing Thermal Ablation Therapy Time Tissues Training Transducers Treatment Efficacy Ultrasonic Transducer United States Work algorithm training cancer diagnosis cancer imaging cancer therapy commercialization cost curative treatments deep learning detection method effective therapy image processing imaging system improved in vivo in vivo Model in vivo evaluation innovation microwave electromagnetic radiation minimally invasive porcine model real time monitoring real-time images sensor simulation targeted delivery tool tumor ultrasound

Ablation Acoustics Address Adult Affect Algorithms Anatomy Animals Arteries Atrial Fibrillation Breast Cardiac ablation Childhood Cryosurgery Data Databases Detection Development Devices Disease Epilepsy Family suidae Feedback Focused Ultrasound Therapy Goals Incidence Intervention Kidney Left Liver Liver neoplasms Location Lung Malignant Neoplasms Malignant neoplasm of liver Marketing Methods Modeling Needles Neurologic Newly Diagnosed Operative Surgical Procedures Patient risk Patients Performance Perfusion Phase Physics Pilot Projects Population Positioning Attribute Procedures Property Recurrent tumor Regulatory Pathway Resolution Screening for Hepatocellular Cancer Shapes Site Small Business Innovation Research Grant Solid Neoplasm Structure Surgeon Survival Rate Techniques Technology Testing Thermal Ablation Therapy Time Tissues Training Transducers Treatment Efficacy Ultrasonic Transducer United States Work algorithm training cancer diagnosis cancer imaging cancer therapy commercialization cost curative treatments deep learning detection method effective therapy image processing imaging system improved in vivo in vivo Model in vivo evaluation innovation microwave electromagnetic radiation minimally invasive porcine model real time monitoring real-time images sensor simulation targeted delivery tool tumor ultrasound

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项目摘要

Project Summary A significant number (~30-50%) of liver cancers have no curative treatments due to their proximity to critical anatomy. Minimally invasive thermal ablation is a promising treatment for these untreatable solid tumors. If delivered precisely, ablations offer the treatment efficacy of traditional surgery with lower patient risk, clinician time, and overall cost. Existing ablation technology, however, does not offer the necessary precision. Ablation tools do not provide feedback on (1) whether or not the probe has been accurately placed within the tumor, (2) if the tumor has been completely destroyed, or (3) if surrounding healthy tissue has been left intact. Because of this lack of precision and feedback, ablation cannot currently be used to treat tumors near critical anatomy. A proposed solution to these currently untreatable cancers is an ultraprecise ablation needle, embedded with high-resolution ultrasound sensors at its tip. These sensors will provide multiple benefits: aiding the clinician in placing the device correctly by imaging the tumor relative to the needle, delivering the treatment energy to a precise location through focusing, and providing real-time monitoring of the procedure by detecting the thermal changes in tissue-all without the need for a large imaging system. This innovation will allow surgeons to complete an ablation with the required precision to treat even the most difficult-to-reach cancers. This Phase 1 SBIR proposal will demonstrate the capabilities of small-scale ultrasound transducers to precisely control ablations near critical anatomical structures (e.g., arteries) in an in vivo porcine model through three specific aims: (1) optimization of previously developed ultrasound-based ablation zone estimation in ex vivo liver tissue using deep learning and physics-based simulations, (2) ablation zone estimation in an in vivo porcine liver model, and (3) demonstration of in vivo closed-loop ablation zone control near critical anatomy (artery in liver). Completion of this phase will demonstrate the key technology in a pilot animal study, where Phase 2 work would address critical development milestones to commercialization for an anticipated Class 2 device (approval via de nova regulatory pathway).

项目摘要大量（〜30-50％）的肝癌由于靠近关键而没有治愈治疗解剖学。微创热消融是对这些不可治疗的实体瘤的有希望的治疗方法。如果精确地交付，消融提供了传统手术的治疗疗效，患者风险较低，临床医生时间和整体成本。但是，现有的消融技术没有提供必要的精度。消融工具不提供（1）是否已准确地放置探针的反馈肿瘤，（2）如果肿瘤已被完全破坏，或（3）如果围绕健康组织完好无损的。由于缺乏精度和反馈，目前不能使用消融来治疗附近的肿瘤关键解剖学。针对这些目前不可治疗的癌症的提议解决方案是一种超脑消融针，嵌入高分辨率超声传感器的尖端。这些传感器将提供多种好处：协助临床医生通过对针相对于针的肿瘤成像正确放置设备，将治疗能量输送到通过聚焦，并通过检测到实时监视该过程的精确位置无需大型成像系统而无需进行组织的热变化。这项创新将允许外科医生以所需的精度完成消融，以治疗最难触觉的癌症。该第1阶段SBIR提案将证明小规模超声传感器的功能精确控制临界解剖结构（例如动脉）附近的消融通过三个特定目的：（1）优化先前开发的基于超声的消融区使用深度学习和基于物理的模拟估算离体肝组织，（2）消融区体内猪肝模型中的估计，（3）体内闭环消融区的演示在关键解剖结构（肝脏中的动脉）附近的控制。此阶段的完成将展示关键技术在一项试点动物研究中，第二阶段工作将解决关键发展里程碑预期的2类设备的商业化（通过NOVA监管途径批准）。