Image-guided ultrasound ablation for precision targeting of prostate cancer

摘要 前列腺癌是主要的癌症诊断和男性死亡的第二大原因，影响到 美国每六个男人中就有一个放射治疗或手术被认为是治疗的黄金标准。 前列腺癌的器官局限性疾病的治疗方式通常具有良好的结果，但可以 导致失禁、阳痿、直肠出血和尿道烧灼。程序费用，完整程序 持续时间和治疗输送持续时间仍然是问题。多参数MRI的最新进展和注册 活组织检查技术可以识别前列腺内主要病变（DIL）的区域，以分期和靶向肿瘤。在 考虑替代电离辐射或膀胱切除术及其相关的发病率，最近 临床研究已经证明了热消融技术的潜在作用。虽然前景看好，但这些 介入技术对消融区的形状和范围的控制有限，需要多个或 重叠插入，经常有不必要的并发症。图像引导的HIFU产生多个小的 消融区域，需要重新定位焦点以增加体积，但立即瞄准区域 邻近直肠或前列腺前部的MRI引导系统是困难的，MRI引导系统需要复杂且昂贵的 基础设施和长期治疗。介入正常组织、气体和骨骼是有问题的。那里 是当前应用的消融系统的固有特性，其（i）限制了它们真正递送的能力， 病灶的适形破坏，同时最大限度地减少对直肠或神经血管束（NVB）的损伤， (ii)需要相当长的手术时间，和/或（iii）在有限数量的中心是复杂的，并且需要 昂贵的基础设施。申报的微创组织间针高强度超声施源器 具有高度适形和穿透性的加热模式，结合3D跟踪超声图像引导， 治疗计划、术中治疗监测，可以结合起来，提供一种理想的机制， 前列腺的精确热疗。这个项目的目标是发展一个形象- 引导间质超声消融系统结合MP-MRI与US图像配准，电磁 跟踪和活检图，用于真正的3D可控和适形热消融，用于治疗早期 分期定位和识别高危前列腺癌，比现有的方法更快、更实用 技术.与HIFU不同，我们的设备在图像引导下直接放置到目标中以治疗疾病 局灶性而不影响其他组织，具有更短的510（k）FDA许可路径。 我们的方法和技术将提供复杂的，高度集成的3D适形治疗， 易于传播，并且对于主流急性护理医院和门诊手术中心是实用的。我们 建议开发一种疗程短、副作用少的前列腺癌精确靶向治疗方法， 比放疗或手术更有效。该项目的主要目标是完成一个超声图像 引导超声消融系统治疗前列腺癌，并在FDA GLP研究中进行性能验证。

ABSTRACT Prostate cancer is the leading cancer diagnosis and the second leading cause of death in men, affecting one of every six men in the United States. Radiation therapy or surgery are considered the gold standard of treatment modalities for prostate cancer for organ confined disease with generally excellent outcomes, but can result in incontinence, impotence, rectal bleeding and urethral burning. Procedure costs, complete procedure duration, and therapy delivery duration remain issues. Recent advances in multi-parametric MRI and registered biopsy techniques can identify regions of dominant intraprostatic lesions (DIL) to stage and target tumors. In consideration of an alternative to ionizing radiation or prostatectomy and their associated morbidity, recent clinical studies have demonstrated the potential role of thermal ablative techniques. Although promising, these interventional technologies have limited control of the shape and extent of the ablation zone, require multiple or overlapping insertions, often with unnecessary complications. Image-guided HIFU produces multiple small ablation zones and require repositioning of focus to increase volume, but targeting regions immediately adjacent to the rectum or in the anterior prostate is difficult, MRI guided systems require complex and costly infrastructure, and long treatment durations. Intervening normal tissues, gas, and bone are problematic. There are inherent characteristics of currently applied ablation systems that (i) limit their ability to deliver truly conformal destruction of focal disease while minimizing damage to the rectum or neurovascular bundle (NVB), (ii) require significantly long procedure times, and/or (iii) are complex, at limited number of centers, and require expensive infrastructure. Proposed minimally invasive interstitial needle high-intensity ultrasound applicators with highly conformal and penetrating heating patterns, coupled with 3D tracked ultrasound image guidance, treatment planning, intraprocedure therapy monitoring, can be combined to provide an ideal mechanism for conformable precise thermal surgery in prostate. The objective of this project is development of an image- guided interstitial ultrasound ablation system combined with MP-MRI to US image registration, electromagnetic tracking, and biopsy maps for truly 3D controllable and conformal thermal ablation for treatment of both early stage localized and identified high-risk prostate cancer, which is faster and more practical than existing technologies. Unlike HIFU, our device is placed directly into the target under image guidance to treat disease focally without affecting other tissues, with a much shorter 510(k) FDA clearance path. Our approach and technology will provide sophisticated, highly-integrated 3D conformal therapy which is readily disseminated and is practical for mainstream acute care hospitals and outpatient surgery centers. We propose to develop a short duration treatment, precisely targeted therapy for prostate cancer with less side effects than radiation or surgery. The major goal of the proposed project is to complete an ultrasound image guided ultrasound ablation system to treat prostate cancer and performance validation in FDA GLP study.