Prostate Cancer Diagnosis by Multiparametric Ultrasound

多参数超声诊断前列腺癌

基本信息

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
项目类别：
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

项目摘要

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 PSA 筛查相关死亡的 9%。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 PCa 的过度治疗。最近的研究表明迫切需要有选择地进行治疗。确定具有“临床意义”的 PCa，这将导致 PCa 的治疗具有成本效益。多参数 MRI (mp-MRI) 已成为诊断侵袭性 PCa 的护理标准。 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，此外，由于 mp-MRI 的成本较高，因此会漏掉相当多的临床重要病变。 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，有最近的研究表明，需要一种更具成本效益的替代方案来检测高级别 PCa。超声造影 (CEUS) 可以选择性地检测出患有“临床显着”PCa 的患者。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。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- US）用于检测“有临床意义”的 PCa。我们将比较 3D mp-US 和 mp-MRI，以确定显着的意义。 PCa（定义为：格里森评分 ≥ 7、单个核心受累程度 > 50%，或活检核心 > 25% 呈阳性） PCa 或格里森分级组 ≥ 2、PSA > 10 或临床分期 cT2b 或更差）。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 在第二年，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对前列腺进行横直肠超声评估与 mp-US 进行比较，最多 3 个。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。