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

摘要：在美国，每年有超过100万例活检被诊断为前列腺癌 (PCA)[1]。在下列情况下，使用经直肠超声(TRUS)引导进行前列腺活检以诊断前列腺癌 怀疑是通过筛选机制提出的。然而，超声前列腺成像不利于将活检定位于可疑区域，因为前列腺癌没有独特的B型图像特征，可以 将病变组织与正常结构和良性病变区分开来。因此，目前的标准是 CARE的敏感性很差，主要是因为抽样网格只能随机抽样5%的前列腺 与病理组织相交。因此，无论是fi一次还是二次，主成分分析的检测率都只有18-36 重复活组织检查[1-5]。此外，通过系统抽样方法检测到的许多癌症 临床上fi不能[2，6]，导致过度激进的治疗，对患者和地方造成不利影响 这给我们的医疗体系带来了不必要的负担。在之前的融资周期中，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。我们的经验是 在100多名患者中进行的3DARFI前列腺成像显示了3DARFI成像令人兴奋的结果 fic是临床有症状的慢性阻塞性肺疾病(ficsd)[7]，这意味着它可以用来筛查整个 前列腺靶向CSD可疑区域的活检。我们已经认识到了必须解决的关键技术挑战，以带来低成本、3D-ARFI前列腺癌筛查和有针对性的fi 将活检引导系统纳入目前的临床工作--flow。在这场竞争的续期中，按票面价值提交- 15-075对于学术-产业合作，我们建议与西门子超声波公司合作解决这些问题 挑战和构建临床就绪系统，并评估其在临床中的表现，与系统 经皮超声活检。拟议的系统将消除系统抽样的随机性，便于根据腺体中存在的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组织检查芯数、重复活组织检查程序的次数以及 与前列腺癌相关的不必要的根治性前列腺切除术的数量。fic的目标有三个：1)翻译 我们的原型系统通过：开发和集成一个定制设计的， Side-fiRe经直肠换能器和活检针导向器，实现我们的数据处理和3D数据 可视化工具搭载在最先进的超声扫描仪原型上，并在机动旋转系统中集成了定位反馈。2)评估3D TRUS ARFI靶向活检的效果 组织模拟体模中的引导系统。3)评估3D ARFI在人体内的表现 在针对临床有意义的前列腺疾病方面，fi不能。

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 targeting 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 technical 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, facilitating 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 feedback 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.