Prostate Cancer Diagnosis by Multiparametric Ultrasound

多参数超声诊断前列腺癌

• 批准号: 10199974
• 负责人: Flemming Forsberg
• 金额: $ 60.65万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10199974
• 关键词: 3-Dimensional; Accounting; American; Area; Behavior; Biological Markers; Biopsy; Cessation of life; Clinical; Clinical Trials; Colorectal; Contrast Media; Core Biopsy; Country; Detection; Diagnosis; Disease; Early Diagnosis; Early treatment; Elasticity; Engineering; European; Evaluation; Gadolinium; Geography; Gleason Grade for Prostate Cancer; Histopathology; Home; Image; Imaging technology; Industry; Intervention; Kidney Failure; Kinetics; Lead; Left; Lesion; Localized Malignant Neoplasm; Lung; Machine Learning; Magnetic Resonance Imaging; Malignant Neoplasms; Malignant neoplasm of prostate; Medial; Meta-Analysis; Methods; Microbubbles; Morbidity - disease rate; Neighborhoods; Ovarian; PSA screening; Participant; Pathologic; Patients; Pilot Projects; Predictive Value; Prostate; Prostate Cancer therapy; Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial; ROC Curve; Radical Prostatectomy; Randomized; Resources; Scanning; Scientist; Screening for Prostate Cancer; Signal Transduction; Specificity; Structure of base of prostate; System; Techniques; Time; Tissues; Transrectal Ultrasound; Ultrasonography; Viscosity; Visualization; base; cancer diagnosis; clinically significant; contrast enhanced; cost; cost effective; cost effective intervention; cost effective treatment; detection method; diagnostic accuracy; editorial; improved; industry partner; male; men; mortality; novel; novel marker; overtreatment; portability; screening; screening program; socioeconomics; standard of care; technology/technique; treatment program; viscoelasticity

Prostate cancer (PCa) is the most frequently diagnosed cancer among American males, accounting for 20% of new cancer diagnoses, but PCa is directly responsible for only 9% of cancer related deaths. PSA screening facilitates the detection of PCa, but many of the cancers detected by PSA screening are low to intermediate grade, resulting in overtreatment of non-aggressive PCa. Recent studies suggest an urgent need to selectively identify “clinically significant” PCa that will result in cost-effective treatment of PCa. In the past few years, multiparametric MRI (mp-MRI) has become the standard of care for diagnosis of aggressive PCa. Although mp- MRI guided biopsy can selectively detect higher grade PCa lesions, several recent studies acknowledge that a considerable number of clinically important lesions are missed by mp-MRI. Furthermore, given the high cost of MRI, the geographic variability in the availability of MRI systems, the inexact methods used to register and fuse MRI with ultrasound for biopsy, and the dangers of Gadolinium in patients with renal insufficiency, there is a need for a more cost-effective, alternative to detect high-grade PCa. Recent studies have demonstrated that contrast-enhanced ultrasound (CEUS) can selectively detect patients with “clinically significant” PCa. New methods have been proposed to enhance conventional ultrasound detection of PCa, including subharmonic imaging (SHI), contrast-enhanced ultrasound dispersion imaging (CUDI) and viscoelastography. The objective of this project is to develop a system capable of a multiparametric combination of ultrasound techniques (mp- US) for detection of “clinically significant” PCa. We will compare 3D mp-US and mp-MRI to identify significant PCa (defined as: Gleason score ≥ 7, a single core with > 50% involvement, or > 25% of biopsy cores positive for PCa or as Gleason grade group ≥ 2, PSA > 10 or clinical stage of cT2b or worse). The first year of the study will be dedicated to implementation of our mp-US technique on a commercially available 3D transrectal probe, and to adapting a MRI-based fusion/registration system to mp-US. During the second year, we will optimize mp-US with a machine learning approach, based upon pathologic correlation with 50 radical prostatectomy patients. The final 3 years of the study will be dedicated to a clinical trial with 300 participants suspected of having PCa. Each participant will receive an experimental intervention in the form of biopsy of up to 3 suspicious areas identified by transrectal ultrasound evaluation of the prostate with mp-US. For comparison, a maximum of 3 targeted biopsy cores will also be obtained from each participant, based on mp-MRI (the clinical intervention). Following the targeted biopsy, each participant will also receive a systematic biopsy (standard of care) consisting of 6 laterally directed biopsy cores and 6 medially directed biopsy cores. The study is powered to demonstrate that targeted biopsy based upon mp-US is not inferior to targeted biopsy based upon mp-MRI.

前列腺癌 (PCa) 是美国男性中最常诊断出的癌症，占美国男性的 20% 新的癌症诊断，但前列腺癌仅直接导致癌症相关死亡的 9%。 PSA筛查 有助于前列腺癌的检测，但 PSA 筛查检测到的许多癌症都是低度到中度的 级，导致非侵袭性前列腺癌的过度治疗。最近的研究表明迫切需要有选择地 确定“具有临床意义”的 PCa，从而实现具有成本效益的 PCa 治疗。在过去的几年里， 多参数 MRI (mp-MRI) 已成为诊断侵袭性 PCa 的护理标准。虽然 mp- MRI 引导活检可以选择性地检测更高级别的 PCa 病变，最近的几项研究承认， mp-MRI 遗漏了相当多的临床重要病变。此外，考虑到高昂的成本 MRI、MRI 系统可用性的地理差异、用于注册和融合的不精确方法 MRI 与超声活检，以及肾功能不全患者中钆的危险，有 需要一种更具成本效益的替代方案来检测高级 PCa。最近的研究表明 超声造影 (CEUS) 可以选择性地检测出患有“临床显着”PCa 的患者。新的 已经提出了增强 PCa 常规超声检测的方法，包括次谐波 成像（SHI）、对比增强超声弥散成像（CUDI）和粘弹性成像。目标 该项目的目的是开发一个能够多参数组合超声技术的系统（mp- 美国）用于检测“有临床意义”的 PCa。我们将比较 3D mp-US 和 mp-MRI 以确定显着性 PCa（定义为：格里森评分 ≥ 7，单个核心受累程度 > 50%，或 > 25% 的活检核心阳性 PCa 或格里森分级组 ≥ 2、PSA > 10 或临床分期 cT2b 或更差）。研究的第一年将 致力于在市售 3D 经直肠探头上实施我们的 mp-US 技术，并且 使基于 MRI 的融合/配准系统适应 mp-US。第二年，我们将优化 mp-US 采用机器学习方法，基于 50 名根治性前列腺切除术患者的病理相关性。 该研究的最后 3 年将致力于一项临床试验，有 300 名疑似患有 PCa 的参与者参加。 每位参与者将接受最多 3 个可疑区域活检形式的实验干预 通过使用 mp-US 对前列腺进行经直肠超声评估来确定。为了比较，最多 3 基于 mp-MRI（临床干预），还将从每个参与者处获得有针对性的活检核心。 在有针对性的活检之后，每个参与者还将接受系统活检（护理标准），其中包括 6 个横向定向活检核心和 6 个内侧定向活检核心。该研究旨在证明 基于 mp-US 的靶向活检并不逊色于基于 mp-MRI 的靶向活检。