Image guided targeted biopsy of clinically significant prostate cancer with acoustic radiation force

翻译后摘要：在美国每年进行超过100万活检诊断前列腺癌 （PCa）[1]。在以下情况下，使用经直肠超声（TRUS）引导进行前列腺活检以诊断PCa： 通过甄别机制提出怀疑。然而，超声前列腺成像并不有利于焦油- 对可疑区域进行活检，因为PCa没有独特的B型图像特征， 从正常结构和良性病变中描绘出患病组织。因此，目前的标准 CARE的灵敏度很差，主要是因为对<5%的前列腺进行采样的采样网格仅是随机的 与病理组织相交因此，首次和第二次PCa检测率仅为18-36% 重复活检[1-5]。此外，许多通过系统抽样方法检测到的癌症 在临床上无意义[2，6]，导致过度积极的治疗，对患者和地方产生不利影响 给我们的医疗系统带来不必要的负担在上一个融资周期中，我们开发了一种新颖的3D 声辐射力脉冲（ARFI）前列腺超声弹性成像系统。我们的经验与 100多例患者的3D ARFI前列腺成像显示了令人兴奋的结果， 是特异性的临床重大疾病（CSD）[7]，这意味着它可以用来筛选整个 前列腺和可疑CSD区域的目标活检。我们已经确定了艾德的关键技术 必须解决的临床挑战，以实现低成本，3D-ARFI前列腺癌筛查和靶向 活检引导系统进入目前的临床工作中-在这个竞争性的更新，根据PAR提交- 15-075对于学术-工业合作，我们建议与西门子超声合作解决这些问题 挑战，建立一个临床准备系统，并评估其在临床上的表现，与系统相比， TRUS活检。拟议的制度将消除有系统抽样的随机性质，方便- 根据腺体中最具侵袭性的疾病进行初步诊断。我们假设 该系统将减少所需的活检芯数量、重复活检程序的数量以及 与PCa相关的不必要的根治性前列腺切除术的数量。有三个具体目标：（1）翻译 我们的原型系统，成为一个临床准备系统，通过：开发和集成的定制设计， 侧射经直肠传感器和活检针导向器，我们的数据处理和3D数据的实施 最先进的原型超声扫描仪上的可视化工具，以及定位馈送的集成， 回到电动旋转系统中。2)评估3D TRUS ARFI靶向活检的性能 组织模拟体模中的引导系统。3)评估人体内3D ARFI的性能 针对临床上严重的前列腺疾病。

Abstract: Over 1,000,000 biopsies are performed annually in the United States to diagnose prostate cancer (PCa)[1]. Prostate biopsies are performed using transrectal ultrasound (TRUS) guidance to diagnose PCa when suspicion is raised through screening mechanisms. However, ultrasonic prostate imaging does not facilitate tar- geting biopsies to suspicious regions because PCa does not have unique B-mode image characteristics that can delineate diseased tissues from normal structures and benign pathologies. Therefore, the current standard of care has poor sensitivity mainly because the sampling grid, which samples <5% of the prostate, only randomly intersects pathologic tissues. As a result, PCa detection rates are only 18-36% for both first and second-time repeat biopsies[1–5]. In addition, many of the cancers that are detected with the systematic sampling approach are clinically insignificant [2, 6], leading to overly aggressive treatment that adversely affects patients and places an unnecessary burden on our healthcare system. During the previous funding cycle we developed a novel 3D Acoustic Radiation Force Impulse (ARFI) prostate ultrasound elasticity imaging system. Our experience with 3D ARFI prostate imaging in over 100 patients demonstrated the exciting result that 3D ARFI imaging is specific for clinically significant disease (CSD)[7], which means it can be used to screen the entire prostate gland and target biopsies toward regions suspicious for CSD. We have identified the key tech- nical challenges that must be addressed to bring a low-cost, 3D-ARFI prostate cancer screening and targeted biopsy guidance system into the current clinical work-flow. In this competing renewal, submitted under PAR- 15-075 for academic-industrial collaborations, we propose to partner with Siemens ultrasound to resolve these challenges and build a clinic-ready system and assess its performance in the clinic as compared to systematic TRUS biopsy. The proposed system will remove the random nature of systematic sampling, facilitat- ing initial diagnosis based upon the most aggressive disease present in the gland. We hypothesize that this system will reduce the required number of biopsy cores, the number of repeat biopsy procedures, and the number of unnecessary radical prostatectomies associated with PCa. There are 3 specific aims: 1) To translate our prototype system into a clinic-ready system through: development and integration of a custom designed, side-fire transrectal transducer and biopsy needle guides, implementation of our data processing and 3D data visualization tools on-board a state-of-the-art prototype ultrasound scanner, and integration of positioning feed- back in the motorized rotation system. 2) To assess the performance of the 3D TRUS ARFI targeted biopsy guidance system in tissue mimicking phantoms. 3) To assess the performance of 3D ARFI in vivo in humans in targeting clinically significant prostate disease.