Quantitative Detection Efficiency of UDFF for Nonalcoholic Fatty Liver Disease (UDFF)

April 6, 2023 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Quantitative Detection Efficiency of Ultrasound Derived Fat Fraction (UDFF) as a Non-invasive Alternative for Nonalcoholic Fatty Liver Disease (CHESS2303): a Multicenter Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide characterized by excessive accumulation of triglycerides in hepatocytes and subsequent steatosis, 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). NALFD is strongly associated with metabolic risk factors, such as obesity, cardiovascular disease, and diabetes mellitus. Early detection and treatment may halt or reverse NAFLD progression. However, the occurrence and progression of steatosis and fibrosis had no obvious clinical symptoms, resulting in a difficulty of early diagnose and grade individuals with NAFLD clinically.

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. Several imaging modalities have been used to diagnose and grade hepatic steatosis. 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 most commonly used noninvasive method that quantifies the amount of fat in the liver is the controlled attenuation parameter, and more than 10% of steatosis can be distinguished. The disadvantages of this technique are that the liver morphological changes cannot be assessed simultaneously and poor performance in patients with higher body mass indices, leading to a failure rate of measurement ranged of 7.7 % - 14.0 %.

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bozhou, Anhui, China, 236000
        • Not yet recruiting
        • The People's Hospital of Bozhou
        • Contact:
          • Zhou Wang, M.D.
      • Hefei, Anhui, China, 230601
        • Not yet recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Fan Jiang, M.D.
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Xiaodong Zhang, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Chuanlong Zhu, M.D.
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Zhongda Hospital, Southeast University
        • Contact:
          • Jia Li, M.D.
      • Zhenjiang, Jiangsu, China, 212021
        • Not yet recruiting
        • Zhe Third People's Hospital of Zhenjiang
        • Contact:
          • Yumei Yin, M.D.
    • Jilin
      • Changchun, Jilin, China, 130000
        • Not yet recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
          • Xiaofeng Sun, M.D.
    • Shandong
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Shandong Public Health Clinical Center
        • Contact:
          • Rong Shan, M.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Xinhua Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Yi Dong, M.D.
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
        • Contact:
          • Lingyun Bao, M.D.
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Affiliated Hangzhou Xixi Hospital, Zhejiang University School of Medicine
        • Contact:
          • Jiansong Gao, M.D.
      • Lishui, Zhejiang, China, 323000
        • Not yet recruiting
        • Lishui People's Hospital
        • Contact:
          • Jianming Lei, M.D.
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Shihao Xu, M.D.
  • Switzerland
    • Kanton Bern
      • Bern, Kanton Bern, Switzerland, 200032
        • Not yet recruiting
        • Kliniken Hirslanden Beau Site, Salem und Permancence
        • Contact:
          • Christoph F Dietrich, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients were fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological and clinical manifestation.

Description

Inclusion Criteria:

  1. be at least 18 years of age.
  2. fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological (MRI-PDFF values > 5%) and clinical manifestation.
  3. fulfilled diagnosis of hepatic fibrosis with non-alcoholic fatty liver disease based on radiological (LSM by MRE > 3.02kPa) and clinical manifestation.
  4. Willing to participate in this research and sign the informed consent.

Exclusion Criteria:

  1. with liver dysfunction at the terminal stage or are ready for liver transplantation.
  2. with viral hepatitis, autoimmune hepatitis, and alpha-1-antitrypsin deficiency.
  3. history of excessive drinking (the amount of alcohol consumed by women is more than 140 grams per week, and that of men is more than 210 grams per week).
  4. unable to cooperate with ultrasound examinations.
  5. have taken liver damage drugs within the past six months.
  6. with massive ascites.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Training cohort

Patients were fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological and clinical manifestation.

Patients were fulfilled diagnosis of hepatic fibrosis based on radiological and clinical manifestation.
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.
Validation cohort

Patients were fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological and clinical manifestation.

Patients were fulfilled diagnosis of hepatic fibrosis based on radiological and clinical manifestation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficiency of UDFF (in %) for hepatic steatosis in comparison with MRI-PDFF (in %).
Time Frame: 1 years
Evaluate the diagnosis performance of ultrasound-derived fat fraction (UDFF) as a quantitative non-invasive alternative for diagnosing and grading of hepatic steatosis in NAFLD patients, taking MRI-PDFF as the reference standard.
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficiency of auto-pSWE (in kPa) for hepatic fibrosis in comparison with MRE (in kPa).
Time Frame: 1 years
Evaluate the diagnosis performance of auto-pSWE as a quantitative non-invasive alternative for diagnosing and grading of hepatic fibrosis in NAFLD patients, taking MRE as the reference standard.
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

The First Affiliated Hospital with Nanjing Medical University
The First Hospital of Jilin University
Zhongda Hospital
Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
The Second Hospital of Anhui Medical University
The First Affiliated Hospital of Xiamen University
Lishui Country People's Hospital
Shandong Public Health Clinical Center
Affiliated Hangzhou Xixi Hospital, Zhejiang University School of Medicine
The People's Hospital of Bozhou
Kliniken Hirslanden Beau Site, Salem und Permancence
Third People's Hospital of Zhenjiang, Jiangsu University

Investigators

  • Study Chair: Jiangao Fan, M.D., Xinhua Hospital, Shanghai Jiaotong University School of Medicine
  • Principal Investigator: Xiaolong Qi, M.D., Zhongda Hospital
  • Study Director: Yi Dong, M.D., Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 26, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESS2303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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