Hepatic Steatosis Quantification with Ultrasound

超声定量肝脏脂肪变性

• 批准号: 10436480
• 负责人: Shigao Chen
• 金额: $ 57.66万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10436480
• 关键词: Affect; Agreement; Algorithms; American; Benchmarking; Biological Markers; Calibration; Cardiovascular Diseases; Classification; Clinical; Detection; Development; Diabetes Mellitus; Diagnosis; Evaluation; Family; Fatty Liver; Fatty acid glycerol esters; Fibrosis; Frequencies; Guidelines; Hepatology; Image; Intervention; Lead; Liver; Liver Cirrhosis; Liver Fibrosis; Magnetic Resonance Elastography; Magnetic Resonance Imaging; Measurement; Measures; Methods; Modeling; Modernization; Noise; Outcome; Patients; Penetration; Performance; Phase; Populations at Risk; Protons; ROC Curve; Reference Standards; Regression Analysis; Reproducibility; Risk; Scanning; Serum; Signal Transduction; Specificity; Speed; Staging; Technology; Testing; Time; X-Ray Computed Tomography; attenuation; cost; cost effective; density; diabetes management; fatty liver disease; follow-up; improved; new technology; non-alcoholic fatty liver disease; nonalcoholic steatohepatitis; novel; patient population; point of care; prototype; rib bone structure; screening; serial imaging; signal processing; sound; ultrasound; wireless

PROJECT SUMMARY Quantification of liver steatosis has weighty implications in management of Nonalcoholic Fatty Liver Disease (a condition affecting 75-100 million Americans), diabetes mellitus, and cardiovascular disease. Serum biomarkers, computed tomography, and existing ultrasound methods have low sensitivity or specificity for steatosis staging. Proton Density Fat Fraction (PDFF) measured by MRI has high accuracy, but is limited by accessibility and cost. Here we propose a novel ultrasound technology, Spectrum Normalization Attenuation Imaging (SNAI), to quantify ultrasound attenuation coefficient for accurate liver steatosis staging. SNAI does not require a calibration phantom, and is robust to rib shadowing as well as phase aberration and reverberation clutter from the body wall. Accuracy of SNAI for steatosis staging is demonstrated by a promising correlation coefficient of 0.91 with MRI-PDFF in 50 patients. In this project, we will prototype, optimize, and evaluate SNAI on a low-cost, pocket-sized, wireless ultrasound probe, which can be conveniently used for screening and follow-up at the point-of-care setting such as the office of a family doctor or hepatologist. Specific Aim 1: Technical Development. We will use phantom and patient studies to advance and optimize SNAI on the the wireless ultrasound probe. Acquisition parameters and post processing algorithms will be optimized for both fundamental and harmonic SNAI imaging. We will suppress reverberation clutter and correct for sound speed mismatch in liver for more accurate steatosis quantification. Specific Aim 2: Patient study. We will use the SNAI prototypes optimized in Aim 1 to study 250 steatosis patients with clinically indicated MRI-PDFF to investigate the efficacy of SNAI for steatosis quantification. Correlation analysis will be performed to assess the association of SNAI with MRI-PDFF. Steatosis will also be categorized as S0, S1, and S2/S3 according to PDFF. Receiver operating characteristic analyses will be performed to evaluate performance of SNAI for detecting ≥S1 and ≥S2. The agreement between SNAI and PDFF classification will be evaluated using the Kappa statistic. Fibroscan CAP will be used for benchmarking. Specific Aim 3: Reproducibility study. Two sonographers and two hepatology residents will repeatedly scan a subset of subjects (50 patients) studied in Aim 2. Intraclass correlation coefficients will be used to evaluate the inter-operator agreement for SNAI measurements. The within patient variance component from the model will provide an estimate of the inter-operator variance, which represents a lower bound for the minimum detectable difference for longitudinal follow-ups. Successful completion of this project will result in a safe, cost-effective, and easily accessible ultrasound solution for accurate quantification of liver steatosis for diagnosis and frequent follow-up of this very large patient population at point-of-care settings such as the office of a hepatologist or family doctor.

项目摘要 肝脏脂肪变性的定量对非酒精性脂肪肝病的治疗具有重大影响（A 影响75-1亿美国人），糖尿病和心血管疾病。血清 生物标志物，计算机断层扫描和现有的超声方法具有低灵敏度或特异性 脂肪变性分期。通过MRI测量的质子密度分数（PDFF）具有很高的精度，但受到限制 可访问性和成本。在这里，我们提出了一种新型的超声技术，频谱归一化衰减 成像（SNAI），以量化超声衰减系数以进行准确的肝脏脂肪变性分期。 Snai做到了 不需要校准幻影，并且可以稳健地遮盖肋骨以及相差和恢复 从身体墙上的混乱。 SNAI用于脂肪变性分期的准确性通过有希望的相关性证明了 50名患者的MRI-PDFF系数为0.91。在这个项目中，我们将原型，优化和评估SNAI 在低成本，袖珍的无线超声探针上，可方便地用于筛查和 诸如家庭医生或肝病学家办公室之类的护理点的后续行动。 特定目标1：技术发展。我们将使用幻影和患者研究来提高和优化 在无线超声探针上进行SNAI。获取参数和后处理算法将是 针对基本和谐波SNAI成像进行了优化。我们将抑制混乱和纠正 对于肝脏中的声速不匹配，以进行更准确的脂肪变性定量。 特定目标2：患者研究。我们将使用在AIM 1中优化的SNAI原型研究250脂肪变性 临床上表明MRI-PDFF的患者研究了SNAI对脂肪变性定量的效率。 将进行相关分析以评估SNAI与MRI-PDFF的关联。脂肪变性也将是 根据PDF，归类为S0，S1和S2/S3。接收器操作特征分析将是 进行评估SNAI的性能以检测≥s1和≥s2的性能。 Snai和 PDF分类将使用KAPPA统计量进行评估。纤维帽将用于基准测试。 特定目标3：可重复性研究。两名超声检查员和两个肝病居民将反复扫描 AIM 2中的受试者（50名患者）的子集（50名患者）。类内相关系数将用于评估 SNAI测量的操作员协议。模型中的患者方差成分 将提供对操作员差异的估计，该方差表示最小的下限 纵向随访的可检测差异。 该项目的成功完成将导致安全，经济高效且易于访问的超声波 解决肝脏脂肪变性的准确定量诊断和经常随访的解决方案 在护理点环境中的患者人数，例如肝病学家或家庭医生的办公室。