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

基本信息

批准号：
10255514
负责人：
Everette C Burdette
金额：
$ 62.94万
依托单位：
ACOUSTIC MEDSYSTEMS, INC.
依托单位国家：
美国
项目类别：
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/10255514
关键词：
3-Dimensional 3D ultrasound Ablation Accounting Affect Algorithms Ambulatory Surgical Procedures Anatomy Anterior Biological Models Biopsy Brachytherapy Breast Diseases Cancer Patient Canis familiaris Cause of Death Characteristics Clinical Clinical Research Cold Therapy Complex Computer Models 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 PSA screening Pathology Patient observation Patients Pattern Performance Physicians Population Positioning Attribute Positron-Emission Tomography Procedures Prostate Prostate Ablation Prostate Cancer therapy Prostatectomy Prostatic Diseases Radiation Radiation therapy Radical Prostatectomy Radiosurgery Rectum Research Research Personnel Research Proposals Robotics Role Safety Shapes Stains System Techniques Technology Therapeutic Thermal Ablation Therapy Time Tissues Transducers Translational Research Transrectal Ultrasound Ultrasonic Therapy Ultrasonics Ultrasonography United States Update Urethra Ursidae Family Validation Work acute care 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 silico in vivo in vivo evaluation individualized medicine 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 ultrasound ablation

项目摘要

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.

抽象的前列腺癌是主要的癌症诊断，也是男性第二大死亡原因，影响美国每六名男性中就有一名。放射治疗或手术被认为是治疗的黄金标准前列腺癌针对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感。手续费用、手续齐全持续时间和治疗持续时间仍然是问题。多参数 MRI 和注册的最新进展活检技术可以识别主要前列腺内病变 (DIL) 的区域，以对肿瘤进行分期和定位。在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。尽管前景广阔，但这些介入技术对消融区域的形状和范围的控制有限，需要多次或多次重叠插入，通常会带来不必要的并发症。图像引导 HIFU 产生多个小消融区域，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前列腺比较困难，MRI 引导系统需要复杂且昂贵基础设施建设和治疗持续时间长。干预正常组织、气体和骨骼是有问题的。那里目前应用的消融系统的固有特征是（i）限制了它们真正提供治疗的能力适形破坏病灶，同时最大限度地减少对直肠或神经血管束（NVB）的损害， (ii) 需要相当长的手术时间，和/或 (iii) 很复杂，中心数量有限，并且需要昂贵的基础设施。提议的微创间质针高强度超声探头具有高度保形和穿透性的加热模式，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，为治疗提供理想的机制。前列腺的适形精确热手术。该项目的目标是开发一个图像- 引导间质超声消融系统结合 MP-MRI 超声图像配准、电磁跟踪和活检图，用于真正的 3D 可控和适形热消融，用于治疗早期对局部和确定的高风险前列腺癌进行分期，比现有方法更快、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来治疗疾病局部治疗而不影响其他组织，510(k) FDA 清除路径更短。我们的方法和技术将提供复杂、高度集成的 3D 适形治疗，易于传播，对于主流急症护理医院和门诊手术中心来说很实用。我们提议开发一种短期治疗、精准靶向治疗、副作用较小的前列腺癌治疗方法效果优于放射线或手术。该项目的主要目标是完成超声图像引导超声消融系统治疗前列腺癌以及 FDA GLP 研究中的性能验证。