Integrated Image-Guided Ultrasound Ablation System for Cancer Management

用于癌症治疗的集成图像引导超声消融系统

• 批准号: 7289872
• 负责人: Peter G Barthe
• 金额: $ 16.14万
• 依托单位: ARDENT SOUND, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-26 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7289872
• 关键词: Ablation; Accounting; Achievement; Acoustics; Algorithms; Area; Basic Science; Blood flow; Caliber; Cancer Patient; Cardiology; Classification; Clinical; Clinical Research; Computer Systems Development; Computer software; Condition; Coupling; Data; Defect; Deposition; Depth; Development; Effectiveness; Elements; Excision; Foundations; Frequencies; Goals; Gynecology; Histologic; Image; Imagery; Implant; In Situ; Invasive; Lesion; Liver; Liver parenchyma; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of liver; Maps; Market Research; Measurement; Measures; Methods; Metric; Monitor; Morphologic artifacts; Motion; Motivation; Movement; Nature; Normal tissue morphology; Numbers; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Output; Pathologic; Patients; Performance; Phase; Phase I Clinical Trials; Photography; Physicians; Physiologic pulse; Placement; Positioning Attribute; Procedures; Public Health; Pulse taking; Range; Rate; Recurrence; Research; Scanning; Selection for Treatments; Severities; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Soft Tissue Neoplasms; Source; Specific qualifier value; Specimen; Speed; Staining method; Stains; Statistically Significant; Structure; System; Systems Integration; Technology; Temperature; Testing; Thermal Ablation Therapy; Time; Tissues; Transplantation; Treatment Protocols; Tumor Tissue; Ultrasonic Therapy; Ultrasonography; Urology; Validation; abstracting; attenuation; base; cancer therapy; clinical application; clinically relevant; computerized data processing; cost; design; image guided therapy; improved; in vivo; innovative technologies; insight; interstitial; miniaturize; mortality; novel; oncology; pre-clinical; research study; respiratory; simulation; soft tissue; software systems; success; treatment planning; tumor; validation studies

DESCRIPTION (provided by applicant): Project Summary/Abstract:The goal of this SBIR project is to develop an integrated, image-guided ultrasound therapy system for soft tissue ablation, including cancer therapy. The motivation for this approach, based on extensive preliminary data, is that image guided bulk ablation using intense ultrasound (IUS) has several benefits compared with currently employed ablation methods, which include: Localization and targeting: the ability to image while positioning the probe, such as during a minimally invasive approach; Treatment planning: the capability to map out therapy based on interstitial, real-time visualization of target tissue; Precise energy deposition: the ability to selectively direct energy to spare critical structures or intervening tissue; and Procedure monitoring: the facility to ultrasonically monitor tissue effects during treatment; and Low cost and complexity compared to noninvasive approaches (e.g., MRI-guided HIFU). Our system will perform ultrasound bulk ablation of liver cancer and other soft tissue tumors using dual functionality (image and ablate) interstitial ultrasound arrays, a recently developed, innovative technology that provides precise image guidance for tumor ablation. Interstitial ultrasound ablation also offers greatly improved selectivity and reduced sensitivity to blood flow cooling effects that limit other thermal ablation methods. In our Phase I study, new image-ablate arrays with improved imaging and focusing capabilities will be designed, developed, and integrated into probes suitable for interstitial ablation. The capability of these probes for intense ultrasound ablation will be specified based on systematic simulation and tissue experiments. Treatment methods for clinically relevant ablation performance, as measured by ablation defect diameter, volumetric ablation rate, and capability for selective ablation with tissue sparing, will thus be specified. An in vivo study using VX2 tumor tissue implanted in rabbit liver will test the feasibility of image-guided ablation of cancer, with pathologic analysis that will provide insight into the effects of our ultrasound bulk ablation methods on malignant vs. normal tissue. Milestones evaluated based on the in vivo results will assess the clinically relevant capabilities of our system for treatment targeting, planning, and selective image-guided ablation of planned treatment zones. This Phase I research will provide the foundation for the thorough preclinical and pilot clinical studies to be performed in a later Phase II project, expected to culminate in development of a clinically and commercially successful ultrasound imaging and ablation system that will significantly improve treatment of focal tumors. Relevance: Liver cancer, both primary and metastatic, is a major public health problem, accounting for the largest cancer-related mortality in the world. Only a small fraction of patients are eligible for curative resection or transplantation; minimally invasive ablation methods provide an important alternative but have significant problems with incomplete treatment, tumor recurrence, and complications caused by imprecise treatment. Our integrated, image-guided ultrasound ablation system will provide more precise, selective, predictable, and consistent ablation of liver cancer as well as other soft tissue tumors, resulting in fewer complications, reduced tumor recurrence, and thus improved outcomes for cancer patients.

描述（由申请人提供）： 项目摘要/摘要：该 SBIR 项目的目标是开发一种用于软组织消融（包括癌症治疗）的集成图像引导超声治疗系统。基于大量初步数据，这种方法的动机是，与目前采用的消融方法相比，使用强超声 (IUS) 的图像引导整体消融具有多种优势，其中包括： 定位和瞄准：在定位探头时进行成像的能力，例如在微创方法期间；治疗计划：能够根据目标组织的间质实时可视化制定治疗方案；精确的能量沉积：能够选择性地将能量引导至关键结构或介入组织；程序监测：在治疗过程中超声监测组织效应的设施；与非侵入性方法（例如 MRI 引导的 HIFU）相比，成本低、复杂性低。我们的系统将使用双功能（成像和消融）间质超声阵列对肝癌和其他软组织肿瘤进行超声整体消融，这是一项最近开发的创新技术，可为肿瘤消融提供精确的图像引导。间质超声消融还大大提高了选择性，并降低了对血流冷却效应的敏感性，这限制了其他热消融方法。在我们的第一阶段研究中，将设计、开发具有改进的成像和聚焦能力的新型图像消融阵列，并将其集成到适合间质消融的探头中。这些探头的强超声消融能力将根据系统模拟和组织实验来确定。因此，将指定临床相关消融性能的治疗方法，通过消融缺陷直径、体积消融率以及保留组织的选择性消融的能力来测量。使用植入兔肝脏中的 VX2 肿瘤组织进行的体内研究将测试图像引导消融癌症的可行性，并通过病理分析深入了解我们的超声整体消融方法对恶性组织与正常组织的影响。根据体内结果评估的里程碑将评估我们的系统在治疗目标、计划和计划治疗区域的选择性图像引导消融方面的临床相关能力。该一期研究将为后续二期项目中进行的全面临床前和试点临床研究奠定基础，预计最终将开发出临床和商业上成功的超声成像和消融系统，该系统将显着改善局灶性肿瘤的治疗。相关性：肝癌，无论是原发性肝癌还是转移性肝癌，都是一个重大的公共卫生问题，是世界上癌症相关死亡率最高的癌症。只有一小部分患者有资格进行根治性切除或移植；微创消融方法提供了一种重要的选择，但存在治疗不彻底、肿瘤复发以及治疗不精确引起的并发症等重大问题。我们的集成图像引导超声消融系统将为肝癌以及其他软组织肿瘤提供更精确、选择性、可预测和一致的消融，从而减少并发症，减少肿瘤复发，从而改善癌症患者的预后。