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（由申请人提供）：由于肝活检的局限性，非常需要无创肝纤维化分期，超声弹性成像在无创肝纤维化分期方面显示出巨大的前景，并且可能比磁共振弹性成像（MRE）具有更高的临床影响。然而，考虑到美国普通人群的肥胖率，基于超声辐射力的商业弹性成像方法的失败率很高。 (35.7%) 以及越来越多需要肝纤维化分期且通常肥胖的非酒精性脂肪性肝炎患者在该项目中，我们将开发并验证一种名为随机外部振动超声弹性成像 (REVUE) 的新型超声成像技术，该技术具有优越的性能。肝纤维化分期的穿透性 REVUE 使用外部机械振动产生穿透整个肝脏的剪切波，采用先进的处理算法将复杂的波场分解为更简单的波场。用于重建大视场定量弹性成像的单向波场。 研究有 3 个目标：在传统超声扫描仪上实施和推进 REVUE 我们将在传统临床扫描仪上实施 REVUE，并研究先进的剪切波生成、检测（通过谐波成像和编码激励）和处理方法，以方便使用。我们将 REVUE 扩展到 3D 成像，以对肝脏进行更准确和全面的评估，目标 1 包括模型和初步人体研究，以验证所开发的技术。我们将使用目标 1 中的 REVUE 原型来研究 45 名 MRE 患者，每个患者将进行 3 次 REVUE 成像会话：每个会话由 3 名超声医师进行 3 次独立扫描（总共 9 次扫描）。中间有 10 分钟的休息时间，第三次在不同的一天进行，将使用组内相关系数 (ICC) 来评估重测的重复性和评分者间的一致性。目标 3：与 MRE 进行体内比较 我们将使用 REVUE 研究 220 名患者，并将结果与​​ MRE 和最先进的超声弹性成像机 (Aixplorer(r)) 进行比较。数据分析包括测量成功率、与 MRE 结果的相关性以及区分纤维化程度最低的患者 (MRE = 2.9kPa) 和纤维化程度低的患者的 ROC（接受者操作特征）性能评估。该项目的成功完成将带来一种快速、低成本、深度穿透的超声弹性成像方法，满足肥胖患者肝纤维化分期的重要需求。该提案为该技术的临床实施提供了明确的途径。