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，也是男性的第二大死亡原因，影响美国每六个人之一。放射治疗或手术被认为是金标准前列腺癌的治疗方式对有限疾病的器官限制疾病，但可以导致尿失禁，无能，直肠出血和尿道燃烧。程序成本，完整的程序持续时间和治疗递送持续时间仍然存在问题。多参数MRI的最新进展和注册活检技术可以识别出主要的肉体内病变（DIL）的区域，以识别分期和靶向肿瘤。在考虑一种替代电离辐射或前列腺切除术及其相关的发病率的替代方案临床研究表明，热烧蚀技术的潜在作用。尽管很有希望，但这些介入技术对消融区的形状和范围的控制有限，需要多个或重叠的插入，通常会出现不必要的并发症。图像引导的HIFU产生多个小型消融区域，需要重新定位以增加体积，但立即针对区域与直肠或前列腺的邻近相邻，MRI引导系统需要复杂而昂贵的系统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。那里是当前应用的消融系统的固有特征，（i）限制其真正交付的能力局灶性疾病的保形破坏，同时最大程度地减少对直肠或神经血管束的损害（NVB），（ii）需要长时间的程序时间和/或（iii）是复杂的，在有限的中心数，需要昂贵的基础设施。提议的微创性插入针头高强度超声涂抹器具有高度保形和穿透加热模式，再加上3D跟踪的超声图像指导，可以将治疗计划，术中治疗监测进行组合，为您提供理想的机制前列腺中的精确热手术。该项目的目的是开发图像 - 指导的间隙超声消融系统与MP-MRI结合给我们图像登记，电磁跟踪和活检图，用于真正3D可控和共形热消融，以早期处理两者阶段局部和确定的高风险前列腺癌，比现有更快，更实用技术。与HIFU不同，我们的设备在图像指导下直接放入目标，以治疗疾病在不影响其他组织的情况下，有510（k）的FDA间隙路径短得多。我们的方法和技术将提供复杂的，高度综合的3D形式疗法，这是容易传播，对于主流急诊医院和门诊手术中心很有实用。我们提议开发短期治疗，精确针对前列腺癌的靶向治疗效果比辐射或手术。拟议项目的主要目标是完成超声图像在FDA GLP研究中，具有指导性超声消融系统来治疗前列腺癌和性能验证。