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

• 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
• 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

 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（由适用提供）：该提案的广泛，长期目标是建立定量超声（QUS）作为一种客观，准确，准确，准确且广泛可用的方法，用于诊断和在美国超过1亿多人的诊断和分级肝脏静脉炎，并在全球范围内有超过1000万人的饮食 活疾病（NAFLD）。我们研究的直接目的是完善和前瞻性地验证QUS技术，以诊断NAFLD的肝脂肪变性。作为此验证的一部分，并在我们的初步研究的支持下，我们将表明QUS优于常规超声检查（CUS），即当前最常用的模态，用于诊断和分级。为了实现这一目标，我们建议对接受当代临床护理肝活检的成年患者进行一项前瞻性，横断面的临床研究，以评估可疑NAFLD或对先前诊断的NAFLD的重新评估。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；肝活检将在组织学上进行评分，以便在存在和肝脂肪变性的情况下。患者的子集将在同一天或不同的日子进行重复的QUS和CUS检查，有时会改变超声仪或扫描仪。与临床研究同时，QUS技术将针对成年肝脏进行定制，从而提高QUS参数的准确性和精度。该提议的核心假设是，QUS优于NAFLD肝脏脂肪变性的诊断和分级的CU。该研究具有以下特定目的：特定目的1。诊断肝脂肪变性的准确性。假设：使用当代肝活检和中央评分的组织学作为参考，对疑似或已知NAFLD的成年患者的肝脏脂肪变性比CUS比CUS更准确。将检查影响QU和CU诊断准确性的患者获取和数据分析因素。特定的目标2。肝脏脂肪变性的评分准确性。假设：使用当代肝活检和中央评分的组织学作为参考，对具有可疑或已知NAFLD的成年患者的肝脏脂肪变性程度比CUS更准确。将检查影响QU和CUS评分准确性的患者获取和数据分析因素。特定目标3。可重复性可重复可重复可重复。假设：QUS提供了更高的（a）当天的可重复性，（b）日期可重复性，（c）兼职者可重复性的可重复性，（d）与可疑或已知NAFLD的成人患者相比，（d）扫描仪间制造商可重复性。将检查影响Q和CU可重复性可重复可重复可重复可重复可重复可重复可重复可重复可重复的数据分析因素。