Ultrasound Elastography for Liver Fibrosis Staging

超声弹性成像用于肝纤维化分期

• 批准号: 9288188
• 负责人: Shigao Chen
• 金额: $ 42.45万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9288188
• 关键词: Adult; Agreement; Algorithms; American; Benchmarking; Biopsy; Body mass index; Clinic; Clinical; Code; Complex; Confidence Intervals; Data; Data Analyses; Detection; Elasticity; Evaluation; Failure; Fatty acid glycerol esters; Fibrosis; General Population; Generations; Human; Image; Imaging technology; Linear Regressions; Liver; Liver Fibrosis; Liver diseases; Magnetic Resonance Elastography; Maps; Measurement; Mechanics; Medical center; Meta-Analysis; Methods; Modeling; Noise; Obesity; Patients; Penetration; Performance; Prevalence; Radiation; Receiver Operating Characteristics; Recruitment Activity; Reference Standards; Reproducibility; Research; Sampling; Scanning; Signal Transduction; Source; Staging; Technology; Testing; Three-Dimensional Imaging; Time; Travel; Ultrasonography; Variant; attenuation; base; cost; elastography; healthy volunteer; in vivo; liver biopsy; nonalcoholic steatohepatitis; novel; portability; prototype; public health relevance; reconstruction; success; technology validation; validation studies; vibration

 DESCRIPTION (provided by applicant): Due to limitations of liver biopsy, there is a great need for noninvasive liver fibrosis staging. Ultrasound elastography has shown great promise for noninvasive liver fibrosis staging and may have higher clinical impact than Magnetic Resonance Elastography (MRE) due to its high accessibility and low cost. However, commercial elastography methods based on ultrasound radiation force have high failure rate in obese patients. This is a serious limitation considering the obesity prevalence in the U.S. general population (35.7%) and the increasing number of nonalcoholic steatohepatitis patients who are in need of liver fibrosis staging and are commonly obese. In this project, we will develop and validate a novel ultrasound imaging technology called Random External Vibration Ultrasound Elastography (REVUE) with superior penetration for liver fibrosis staging. REVUE uses external mechanical vibration to produce shear waves that penetrate throughout the liver. Advanced processing algorithms are employed to decompose the complex wave field into simpler unidirectional wave fields for reconstruction of large field-of-view quantitative elastography. The study has 3 aims. Aim 1: Implement and Advance REVUE on a traditional ultrasound scanner. We will implement REVUE on a traditional clinical scanner and investigate advanced shear wave generation, detection (by harmonic imaging and coded excitation), and processing methods to facilitate convenient clinical usage and reliable performance in obese patients. We will extend REVUE to 3D imaging for more accurate and comprehensive evaluation of the liver. Aim 1 includes phantom and preliminary human studies to validate the technologies developed. Aim 2: Repeatability and reproducibility study. We will use REVUE prototyped in Aim 1 to study 45 MRE patients. Each patient will have 3 REVUE imaging sessions: each session has 3 independent scans performed by 3 sonographers (a total of 9 scans). The first two sessions will be separated by a 10-minute break and the third performed on a different day. Intraclass correlation coefficients (ICC) will used to evaluate the test-retest repeatability and inter-rater agreement. The overall measurement variance will also be estimated for REVUE. Aim 3: In Vivo comparison with MRE. We will use REVUE to study 220 patients and compare results with those of MRE and a state-of-art ultrasound elastography machine (Aixplorer(r)). Data analysis includes measurement success rate, correlation with MRE results, and ROC (receiver operating characteristic) evaluation of performance for separating patients with minimum fibrosis (MRE = 2.9kPa) and patients with advanced fibrosis (MRE = 5.0kPa). Successful completion of this project will lead to a fast and low-cost ultrasound elastography method with deep penetration that meets the vital need for liver fibrosis staging in obese patients. The use of a traditional clinical ultrasound scanner in this proposal provides a clear path to clinical implementation of this technology.

 描述（由适用提供）：由于肝活检的局限性，非常需要非侵入性肝纤维化分期。超声弹性学对非侵入性肝纤维化分期显示了很大的希望，并且由于其高可及性和低成本，可能比磁共振弹性学（MRE）具有更高的临床影响。但是，基于超声辐射力的商业弹性学方法的肥胖患者的失败率很高。考虑到美国普通人群的肥胖症患病率（35.7％）以及需要肝纤维化分期且通常是肥胖的非酒精性脂肪性肝炎患者的数量增加，这是一个严重的局限性。在这个项目中，我们将开发并验证一种新型的超声成像技术，称为随机外部振动超声弹性弹力图（REVUE），具有出色的肝纤维化分期渗透率。 Revue使用外部机械振动产生横穿整个肝脏的剪切波。采用高级处理算法将复杂的波场分解为更简单的单向波场，以重建大型视野定量弹性图。这 研究有3个目标。 AIM 1：对传统的超声扫描仪实施并提高速度。我们将对传统的临床扫描仪实施REV，并研究高级剪切波的产生，检测（通过谐波成像和令人兴奋的编码）以及处理方法，以促进肥胖患者方便的临床用法和可靠的性能。我们将将REDUE扩展到3D成像，以对肝脏进行更准确和全面的评估。 AIM 1包括幻影和初步人类研究，以验证开发的技术。目标2：可重复性和可重复性研究。我们将在AIM 1中使用原型的Revue原型研究45例MRE患者。每个患者将进行3个REV成像会话：每个会话都有3个独立扫描，由3个超声检查员进行（总共9次扫描）。前两个课程将通过10分钟的休息时间分开，而第三个会议将在不同的一天进行。类内相关系数（ICC）将使用用于评估重测的重复性和评估者一致性。总体测量方差还将估算为REVUE。 AIM 3：与MRE进行体内比较。我们将使用REDUE研究220名患者，并将结果与​​MRE和最先进的超声弹力扫描机（Aixplorer（R））进行比较。数据分析包括测量成功率，与MRE结果的相关性以及对分离最小纤维化患者（MRE = 2.9KPA）和晚期纤维化患者（MRE = 5.0KPA）的ROC（接收器操作特征）评估。该项目的成功完成将导致一种快速，低成本的超声弹性图，并具有深度渗透，这满足了肥胖患者对肝纤维化分期的重要需求。在该提案中使用传统的临床超声扫描仪为这项技术的临床实施提供了清晰的途径。