QUS Technology for Diagnosis and Grading of Hepatic Steatosis in NAFLD

用于 NAFLD 肝脂肪变性诊断和分级的 QUS 技术

基本信息

批准号：
8945356
负责人：
ROHIT LOOMBA
金额：
$ 71.38万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-07-01 至 2020-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8945356
关键词：
Adult Affect American Cessation of life Cirrhosis Clinical Clinical Research Data Analyses Development Diagnosis Diagnostic Disease Disease Progression Early Diagnosis Early treatment Equipment Evaluation Failure Fatty Liver Goals Gold Histologic Histology Ionizing radiation Letters Liver Liver diseases Magnetic Resonance Imaging Manufacturer Name Methods Modality Morbidity - disease rate Patients Performance Persons Primary carcinoma of the liver cells Procedures Prospective Studies Reference Standards Reproducibility Research Risk Technology Testing Translating Ultrasonography United States Validation X-Ray Computed Tomography attenuation base chronic liver disease clinical care clinical practice design diagnostic accuracy elastography imaging modality improved liver biopsy liver transplantation non-alcoholic fatty liver novel prospective public health relevance quantitative ultrasound tool

项目摘要

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.

描述（由申请人提供）：该提案的广泛、长期目标是建立定量超声检查（QUS）作为一种客观、准确、精确且广泛可用的方法，用于诊断和分级超过 1 亿人的肝脏脂肪变性在美国和全球超过 10 亿人患有或有患非酒精性脂肪的风险我们研究的直接目标是完善和前瞻性验证 QUS 技术来诊断和分级 NAFLD 的肝脂肪变性，作为验证的一部分并得到我们初步研究的支持，我们将证明 QUS 优于 NAFLD。常规超声检查 (CUS) 是目前最常用的诊断和分级方法。为了实现这一目标，我们建议对接受同期临床护理肝活检的成年患者进行一项前瞻性、横断面临床研究，以评估肝活检的情况。疑似 NAFLD 或对先前诊断的 NAFLD 进行重新评估的患者将在经皮肝活检后 60 天内接受当天的 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程度。 QUS 和 CUS 检查在同一天或不同天进行，有时超声检查师或扫描仪不同在临床研究的同时，QUS 技术将针对成人肝脏进行定制，以进行完善和改进。从而提高QUS参数的准确性和精确度该提案的中心假设是QUS在NAFLD肝脂肪变性的诊断和分级方面优于CUS。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：对于疑似或已知 NAFLD 的成年患者，使用同期数据来诊断肝脂肪变性，QUS 比 CUS 更准确肝活检和集中评分的组织学作为参考，将检查影响 QUS 和 CUS 诊断准确性的因素。假设：QUS 比 CUS 对肝脂肪变性分级更准确。疑似或已知 NAFLD 的成年患者的肝脂肪变性，使用同期肝活检和集中评分的组织学作为影响分级的患者采集和数据分析因素。将检查 QUS 和 CUS 的准确性。具体目标 3. 重复性-再现性假设：QUS 提供更高的 (a) 当日重复性、(b) 日间重复性、(c) 超声医师间再现性。在疑似或已知 NAFLD 的成人患者中，扫描仪制造商间的再现性优于 CUS 影响 QUS 和 CUS 重复性-再现性的患者采集和数据分析因素。将接受检查。