QUS Technology for Diagnosis and Grading of Hepatic Steatosis in NAFLD

 描述（由申请人提供）：本提案的广泛、长期目标是将定量超声检查（QUS）确立为一种客观、准确、精确且广泛可用的方法，用于美国超过1亿人和全球超过10亿人的非酒精性脂肪肝或有非酒精性脂肪肝风险的肝脂肪变性诊断和分级。 肝病（NAFLD）。我们研究的近期目标是完善和前瞻性验证QUS技术，以诊断和分级NAFLD中的肝脂肪变性。作为此次验证的一部分，并得到我们初步研究的支持，我们将证明QUS在诊断和分级方面优于传统超声检查（CUS）（目前最常用的方式）。上级。为了实现这一目标，我们提出了一项前瞻性，横断面临床研究，在成人患者接受同期临床护理肝活检，以评估可疑的NAFLD或重新评估以前诊断的NAFLD。患者将在经皮肝活检后60天内接受同日QUS和CUS研究检查;将对肝活检进行组织学评分，以确定肝脂肪变性的存在和分级。患者亚组将在同一天或不同天接受重复的QUS和CUS检查，有时会改变超声医师或扫描仪。在临床研究的同时，QUS技术将为成人肝脏量身定制，以完善并提高QUS参数的准确性和精密度。该建议的中心假设是QUS在NAFLD肝脂肪变性的诊断和分级方面优于CUS上级。该研究有以下具体目标：具体目标1。诊断肝脂肪变性的准确性。假设：在诊断疑似或已知NAFLD的成人患者是否存在肝脂肪变性方面，QUS比CUS更准确，使用同期肝活检和集中评分的组织学作为参考。将检查影响QUS和CUS诊断准确性的患者采集和数据分析因素。具体目标2。肝脏脂肪变性分级的准确性。假设：在疑似或已知NAFLD的成人患者中，使用同期肝活检和集中评分的组织学作为参考，QUS比CUS更准确地对肝脏脂肪变性程度进行分级。将检查影响QUS和CUS分级准确性的患者采集和数据分析因素。具体目标3。重复性-再现性。假设：在疑似或已知NAFLD的成人患者中，QUS提供了比CUS更高的（a）同日重复性，（B）日间重复性，（c）超声医师间重复性和（d）扫描仪制造商间重复性。将检查影响QUS和CUS重复性-再现性的患者采集和数据分析因素。

 DESCRIPTION (provided by applicant): The broad, long-term objective of this proposal is to establish quantitative ultrasonography (QUS) as an objective, accurate, precise, and widely available method for diagnosis and grading of hepatic steatosis in the over 100 million persons in the United States and over one billion persons worldwide with or at risk for non-alcoholic fatty liver disease (NAFLD). The immediate goal of our research is to refine and prospectively validate QUS technology to diagnose and grade hepatic steatosis in NAFLD. As part of this validation and as supported by our preliminary studies, we will show that QUS is superior to conventional ultrasonography (CUS), the current most commonly used modality, for diagnosis and grading. To achieve this goal, we propose a prospective, cross-sectional clinical study in adult patients undergoing contemporaneous clinical-care liver biopsy for evaluation of suspected NAFLD or re-assessment of previously diagnosed NAFLD. Patients will undergo same-day QUS and CUS research examinations within 60 days of percutaneous liver biopsy; liver biopsies will be scored histologically for presence and grade of hepatic steatosis. Subsets of patients will undergo repeated QUS and CUS examinations on the same day or on different days, sometimes varying either sonographer or scanner. In parallel with the clinical study, the QUS technology will be tailored for adult liver to refine and thus improve accuracy and precision of QUS parameters. The central hypothesis of this proposal is that QUS is superior to CUS for diagnosis and grading of hepatic steatosis in NAFLD. The study has the following specific aims: Specific Aim 1. Accuracy for diagnosing hepatic steatosis. Hypothesis: QUS is more accurate than CUS for diagnosing the presence of hepatic steatosis in adult patients with suspected or known NAFLD, using contemporaneous liver biopsy and centrally scored histology as reference. Patient acquisition and data analysis factors that affect diagnostic accuracy of QUS and CUS will be examined. Specific Aim 2. Accuracy for grading hepatic steatosis. Hypothesis: QUS is more accurate than CUS for grading the degree of hepatic steatosis in adult patients with suspected or known NAFLD, using contemporaneous liver biopsy and centrally scored histology as reference. Patient acquisition and data analysis factors that affect grading accuracy of QUS and CUS will be examined. Specific Aim 3. Repeatability-reproducibility. Hypothesis: QUS provides higher (a) same-day repeatability, (b) between-day repeatability, (c) inter-sonographer reproducibility, and (d) inter-scanner-manufacturer reproducibility than CUS in adult patients with suspected or known NAFLD. Patient acquisition and data analysis factors that affect repeatability-reproducibility of QUS and CUS will be examined.