Quantitative Detection Efficiency of UDFF for Nonalcoholic Fatty Liver Disease

Summary

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide, affecting more than 25 % of the population globally. Approximately 20 % - 25 % of NAFLD patients can develop nonalcoholic steatohepatitis (NASH), which leads to more rapid progression from fibrosis to cirrhosis, and even liver failure or hepatocellular carcinoma (HCC). Early detection and treatment may halt or reverse NAFLD progression.

Although liver biopsy has been the well-accepted clinical reference standard for both diagnosis and staging of the different histological changes in NAFLD, this procedure is invasive with complications such as bleeding and infection, and is unreliable for quantifying steatosis due to sampling errors. Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) currently has been accepted as the preferred alternative to the histological assessment of hepatic steatosis in patients with NAFLD. Magnetic resonance elastography (MRE) provide additional information of inflammation and fibrotic components of NAFLD. However, important limitations hinder the widespread clinical application of MRI, including high cost, low availability, long scan times and exclusion of patients with metal implants.

Ultrasound (US) has been recommended by several guidelines as the first-line screening tool for patients at risk of NAFLD. The developed ultrasound-derived fat fraction (UDFF) is designed to assess hepatic steatosis by estimating the frequency-dependent attenuation coefficient (AC) and backscatter coefficient (BSC) through processing acoustic radiofrequency (RF) signals returned from the liver tissue as fat vesicles in hepatocytes have a different characteristic impedance compared to normal liver tissue. UDFF is available on the Acuson Sequoia ultrasound system (Simens Healthineers, Mountain View, CA, USA), with reference to integrated phantom data to correct for system impact, and produces a UDFF value presented as a fat fraction (%), which is potentially related to MRI-PDFF and can be directly compared with MRI-PDFF. In addition, automatic point shear wave elastography (auto-pSWE) is available on the Acuson Sequoia ultrasound system to obtain liver stiffness measurement (LSM) for assessing hepatic fibrosis, simultaneously with UDFF measurement. The prospective, multicenter study aims to evaluate the efficiency of UDFF as a quantitative non-invasive alternative for NAFLD.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

DIAGNOSTIC_TEST

Hepatic fat fraction and hepatic fibrosis

All patients underwent measurement of UDFF for hepatic fat fraction and auto-pSWE for hepatic fibrosis. All patients underwent measurement of MRI-PDFF for hepatic fat fraction and MRE for hepatic fibrosis as reference standard.

Sponsors & Collaborators

• Zhongda Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Lishui Country People's Hospital

  collaborator OTHER

• Shandong Public Health Clinical Center

  collaborator OTHER_GOV

• Affiliated Hangzhou Xixi Hospital, Zhejiang University School of Medicine

  collaborator UNKNOWN

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• The People's Hospital of Bozhou

  collaborator UNKNOWN

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Kliniken Hirslanden Beau Site, Salem und Permancence

  collaborator UNKNOWN

• Third People's Hospital of Zhenjiang, Jiangsu University

  collaborator UNKNOWN

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Jiangao Fan, M.D. · Xinhua Hospital, Shanghai Jiaotong University School of Medicine

• Xiaolong Qi, M.D. · Zhongda Hospital

• Yi Dong, M.D. · Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• China
• Switzerland

Study Locations