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

利用声辐射力对具有临床意义的前列腺癌进行图像引导靶向活检

• 批准号: 9978722
• 负责人: Kathryn Radabaugh Nightingale
• 金额: $ 46.75万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-18 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9978722
• 关键词: 3-Dimensional; Acoustics; Address; Affect; Appearance; Benign; Biopsy; Calibration; Characteristics; Clinic; Clinical; Clinical Management; Collaborations; Computer software; Core Biopsy; Custom; Detection; Development; Diagnosis; Diagnostic; Digital Rectal Examination; Disease; Feedback; Funding; Gland; Gleason Grade for Prostate Cancer; Goals; Healthcare; Healthcare Systems; Human; Image; Industrialization; Internships; Lead; Malignant Neoplasms; Malignant neoplasm of prostate; Nature; Needle biopsy procedure; Needles; Normal tissue morphology; Pathologic; Pathology; Patient-Focused Outcomes; Patients; Performance; Positioning Attribute; Predictive Value; Procedures; Prostate; Prostate-Specific Antigen; Prostatic Diseases; Radiation; Radical Prostatectomy; Resources; Rotation; Sampling; Screening for Prostate Cancer; Side; Staging; Structure; Structure of base of prostate; System; Technology; Time; Tissues; Transducers; Translating; Transrectal Ultrasound; Treatment Cost; Tumor Tissue; Ultrasonics; Ultrasonography; United States; Visualization software; Work; aggressive therapy; anxiety treatment; base; cancer diagnosis; clinical decision-making; clinical translation; clinically significant; computerized data processing; cost; data visualization; density; design; elastography; experience; graduate student; image guided; imaging platform; imaging system; improved; in vivo; indexing; industry partner; innovation; men; novel; prostate biopsy; prototype; screening; standard of care; three-dimensional visualization

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.

摘要：每年在美国进行超过1,000,000活检以诊断前列腺癌 （PCA）[1]。使用转直肠超声（TRU）指南进行前列腺活检，以诊断PCA 通过筛选机制提高了可疑的。但是，超声前列腺成像不能促进对可疑区域的活检，因为PCA没有独特的B模式图像特征 从正常结构和良性病理中描绘患病的组织。因此，当前的标准 护理的灵敏度较差，主要是因为采样网格<前列腺的5％，仅随机 相交病理组织。结果，第一和第二次的PCA检测率仅为18-36％ 重复活检[1-5]。此外，许多使用系统抽样方法检测到的癌症 在临床上受到微不足道的影响[2，6]，导致过度侵略性治疗对患者和地方产生不利影响 我们的医疗保健系统上的不必要的伯宁。在上一个资金周期中，我们开发了一个新颖的3D 声辐射力冲动（ARFI）前列腺超声弹性成像系统。我们的经验 100多名患者的3D ARFI前列腺成像表明了3D ARFI成像的令人兴奋的结果 特定于临床上重要的疾病（CSD）[7]，这意味着可以用于筛查整个 前列腺腺和针对可疑CSD区域的活检。我们已经确定了必须解决的关键技术挑战，以进行低成本，3D-ARFI前列腺癌筛查并针对目标 活检引导系统进入当前的临床工作流程。在此竞争续约中，根据 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 与系统的 TRUS活检。所提出的系统将消除系统采样的随机性质，从而根据腺体中最侵略性疾病促进初始诊断。我们假设这一点 该系统将减少所需数量的活检核心，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3个特定目的：1）翻译 我们的原型系统通过以下方式进入诊所就绪系统：开发和集成定制设计， 侧面跨直直直骨传感器和活检针头指南，我们的数据处理和3D数据的实施 可视化工具在机板上是最先进的原型超声扫描仪，并集成了电动旋转系统中的定位反馈。 2）评估3D TRUS ARFI靶向活检的性能 模拟幻影的组织中的引导系统。 3）评估人体体内3D ARFI的性能 在靶向临床上显着的前列腺疾病时。