Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05802199
Status:
RECRUITING
Last Update Posted:
2023-04-10
First Post:
2023-03-14
Brief Title:
Quantitative Detection Efficiency of UDFF for Nonalcoholic Fatty Liver Disease
Sponsor:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Organization:
Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Study Overview
Official Title:
Quantitative Detection Efficiency of Ultrasound Derived Fat Fraction UDFF as a Non-invasive Alternative for Nonalcoholic Fatty Liver Disease CHESS2303 a Multicenter Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UDFF
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
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 77 - 140
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
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 77 - 140
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None