Quantitative Detection Efficiency of UDFF for Nonalcoholic Fatty Liver Disease
- Conditions
- Non-alcoholic Fatty Liver Disease
- Interventions
- Diagnostic Test: Hepatic fat fraction and hepatic fibrosis
- Registration Number
- NCT05802199
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- be at least 18 years of age.
- fulfilled diagnosis of non-alcoholic fatty liver disease based on radiological (MRI-PDFF values > 5%) and clinical manifestation.
- fulfilled diagnosis of hepatic fibrosis with non-alcoholic fatty liver disease based on radiological (LSM by MRE > 3.02kPa) and clinical manifestation.
- Willing to participate in this research and sign the informed consent.
- with liver dysfunction at the terminal stage or are ready for liver transplantation.
- with viral hepatitis, autoimmune hepatitis, and alpha-1-antitrypsin deficiency.
- 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).
- unable to cooperate with ultrasound examinations.
- have taken liver damage drugs within the past six months.
- with massive ascites.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Training cohort Hepatic fat fraction and hepatic fibrosis 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. Validation cohort Hepatic fat fraction and hepatic fibrosis 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.
- Primary Outcome Measures
Name Time Method The efficiency of UDFF (in %) for hepatic steatosis in comparison with MRI-PDFF (in %). 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.
- Secondary Outcome Measures
Name Time Method The efficiency of auto-pSWE (in kPa) for hepatic fibrosis in comparison with MRE (in kPa). 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.
Trial Locations
- Locations (14)
Affiliated Hangzhou Xixi Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Kliniken Hirslanden Beau Site, Salem und Permancence
🇨🇭Bern, Kanton Bern, Switzerland
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The People's Hospital of Bozhou
🇨🇳Bozhou, Anhui, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Zhongda Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China
Zhe Third People's Hospital of Zhenjiang
🇨🇳Zhenjiang, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Shandong Public Health Clinical Center
🇨🇳Jinan, Shandong, China
Xinhua Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Lishui People's Hospital
🇨🇳Lishui, Zhejiang, China