Image-guided ultrasound ablation for precision targeting of prostate cancer

图像引导超声消融精确靶向前列腺癌

• 批准号: 9757727
• 负责人: Everette C Burdette
• 金额: $ 56.64万
• 依托单位: ACOUSTIC MEDSYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-07 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9757727
• 关键词: 3-Dimensional; 3D ultrasound; Ablation; Accounting; Acute; Affect; Algorithms; Ambulatory Surgical Procedures; Anatomy; Anterior; Biological Models; Biopsy; Brachytherapy; Breast Diseases; Cancer Patient; Canis familiaris; Caring; Cause of Death; Characteristics; Clinical; Clinical Research; Cold Therapy; Complex; Computer Simulation; Computers; Conformal Radiotherapy; Coupled; Couples; Data; Development; Device Designs; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Disease; Early Diagnosis; Effectiveness; Electromagnetics; External Beam Radiation Therapy; FDA approved; FOLH1 gene; Feedback; Focused Ultrasound Therapy; Freezing; Gases; Gland; Goals; Gold; Heating; Hemorrhage; High-Dose Rate Brachytherapy; Histology; Hospitals; Image; Impotence; Incontinence; Industrialization; Infrastructure; Institution; Intervention; Ionizing radiation; Lesion; Local Therapy; Localized Disease; Location; Magnetic Resonance Imaging; Mainstreaming; Malignant Neoplasms; Malignant neoplasm of prostate; Maps; Methods; Microscopic; Modality; Monitor; Morbidity - disease rate; Necrosis; Needles; Normal tissue morphology; Operative Surgical Procedures; Organ; Outcome; Pathology; Patient observation; Patients; Pattern; Performance; Physicians; Population; Positioning Attribute; Positron-Emission Tomography; Procedures; Prostate; Prostate Ablation; Prostate Cancer therapy; Prostate-Specific Antigen; Prostatectomy; Prostatic Diseases; Radiation; Radiation therapy; Radical Prostatectomy; Radiosurgery; Rectum; Research; Research Personnel; Research Proposals; Robotics; Role; Safety; Shapes; Stains; System; Techniques; Technology; Testing; Therapeutic; Thermal Ablation Therapy; Time; Tissues; Transducers; Translational Research; Transrectal Ultrasound; Ultrasonic Therapy; Ultrasonics; Ultrasonography; United States; Update; Urethra; Ursidae Family; Validation; Work; base; bone; cancer diagnosis; cohort; contrast enhanced; cost; design; dosimetry; effective therapy; elastography; experience; experimental study; high risk; image guided; image registration; imaging probe; implanted sensor; improved; in vivo; in vivo evaluation; innovation; instrumentation; interstitial; man; men; minimally invasive; neurovascular; non-invasive imaging; optimal treatments; preservation; procedure cost; programs; prostate cancer risk; radiation effect; real time monitoring; rectal; response; side effect; skills; standard care; standard of care; surgical risk; targeted treatment; three-dimensional modeling; treatment duration; treatment optimization; treatment planning; tumor

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.

摘要 前列腺癌是男性的主要癌症诊断和第二大死亡原因，影响 美国每六个男人中就有一个。放射治疗或手术被认为是 对于器官受限疾病的前列腺癌的治疗方法通常效果很好，但可以 导致大小便失禁、阳萎、直肠出血和尿路灼伤。程序费用，完整程序 持续时间和治疗提供持续时间仍然是问题。多参数磁共振成像及其配准的研究进展 活检技术可以识别前列腺内病变(DIL)的显性区域，以确定肿瘤的分期和靶点。在……里面 考虑电离辐射或前列腺切除术的替代方案及其相关发病率，最近 临床研究已经证明了热消融技术的潜在作用。尽管前景看好，但这些 介入技术对消融区的形状和范围的控制有限，需要多次或 重叠插入，通常会有不必要的复杂情况。图像引导HIFU产生多个小的 消融区，需要重新定位焦点以增加体积，但立即瞄准区域 邻近直肠或在前列腺前部是困难的，磁共振引导系统需要复杂和昂贵 基础设施和较长的治疗时间。干预正常组织、气体和骨骼是有问题的。那里 当前应用的消融系统的固有特征是：(I)限制了它们真正地提供 局部病变的适形破坏，同时最大限度地减少对直肠或神经血管束(NVB)的损害， (2)需要相当长的程序时间，和/或(3)在有限数量的中心情况下很复杂，并要求 昂贵的基础设施。建议的微创组织间穿刺针高强度超声照射器 具有高度共形和穿透性的加热模式，再加上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，为 适用于前列腺的精密热外科手术。这个项目的目标是开发一种形象- 引导下间质超声消融系统结合MP-MRI对超声图像进行配准，电磁 真正3D可控和适形热消融治疗早期两者的跟踪和活检图 分期定位和识别高危前列腺癌，比现有的更快和更实用 技术。与HIFU不同的是，我们的设备是在图像引导下直接放入靶区进行治疗的 局部性，不影响其他组织，510(K)FDA清除路径要短得多。 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，适用于主流急诊医院和门诊外科中心。我们 建议开发一种短疗程、精确靶向的治疗前列腺癌的方法。 比辐射或手术更有效。拟议项目的主要目标是完成超声成像。 引导超声消融系统治疗前列腺癌及其在FDA GLP研究中的性能验证。