Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785937
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2021-02-28
Brief Title:
Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients
Sponsor:
Azienda Unità Sanitaria Locale Reggio Emilia
Organization:
Azienda Unità Sanitaria Locale Reggio Emilia
Study Overview
Official Title:
Accuracy of Imaging Techniques Including Ultrasound and Magnetic Resonance Imaging in the Diagnosis of Steatohepatitis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Comparison With the Histological Reference Standard
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
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:
ImagingNAFLD
Brief Summary:
Non-alcoholic fatty liver disease NAFLD is a highly prevalent condition and when fatty liver is associated with inflammation and hepatocellular injury steatohepatitis it can lead to fibrosis cirrhosis liver failure and hepatocellular carcinoma Liver biopsy is the gold standard for NAFLD assessment but has several drawbacks Several drugs for NASH are now in phase 2-3 trials and if medical treatments become available non-invasive tools to identify patients who may benefit from a therapeutic intervention will be strongly needed Some imaging methods have shown promising potential in fibrosis and NASH diagnosis This study aims to evaluate the diagnostic accuracy of non-invasive imaging methods including ultrasound US and Magnetic Resonance MR techniques in diagnosing NASH and fibrosis in patients with or at high risk of NAFLD using liver biopsy as the reference standard Consecutive patients with a clinical indication for liver biopsy assessment of NAFLD are enrolled in this non-inferiority study They undergo both a liver US and a multiparametric unenhanced liver MR examination As reference standard histological diagnosis of fibrosis and steatohepatitis made according to the fatty liver inhibition of progression FLIP algorithm is used Sensitivity and specificity of imaging parameters alone or in different combinations will be calculated with the aim of finding one or more tests with at least 90 sensitivityspecificity compared to liver biopsy
Detailed Description:
The estimated overall global prevalence of non-alcoholic fatty liver disease NAFLD is around 25 and projected at 335 in 2030 While simple steatosis without evidence of inflammation and hepatocellular injury non-alcoholic fatty liver is generally a benign condition non-alcoholic steatohepatitis NASH can progress to fibrosis cirrhosis liver failure and hepatocellular carcinoma Since only histological analysis can accurately evaluate NAFLD patterns liver biopsy is the gold standard for assessment and it should be considered in patients who are at increased risk of having steatohepatitis andor fibrosis Major drawbacks are its invasive nature risk of complications sampling errors and inter and intra-observer variability Currently there are no approved therapies for NASH However several drugs are now in phase 2 and 3 trials and results are expected in 1-2 years If medical treatments become available screening for steatohepatitis and fibrosis will be recommended in high-risk patients The lack of non-invasive tools to identify patients who may benefit from a therapeutic intervention is a central issue Should liver biopsy be avoided or reserved for a more limited number of undetermined or high-risk patients the benefit-harm balance of NASH screening and therapies would undergo a major change Some imaging methods mostly ultrasound US or Magnetic Resonance MR techniques have shown promising potential in fibrosis and NASH diagnosis
The objective of this study is to evaluate the diagnostic accuracy of non-invasive imaging techniques including US and MR methods in diagnosing NASH and fibrosis in patients with or at high risk of NAFLD using liver biopsy as the reference standard
Consecutive patients with a clinical indication for liver biopsy assessment of NAFLD are enrolled in this non-inferiority study They undergo both a liver ultrasound US including shear wave elastography SWE with liver stiffness measurement and US- fatty liver index US-FLI and a multiparametric unenhanced liver magnetic resonance examination including MR spectroscopy MRS Proton Density Fat Fraction PDFF and T2 measurement with Multiecho technique T1 mapping with Inversion Recovery method and Intravoxel Incoherent Motion diffusion weighted imaging IVIM-DWI measuring different parameters As reference standard histological diagnosis of fibrosis and steatohepatitis made according to the fatty liver inhibition of progression FLIP algorithm is used Sensitivity and specificity of imaging parameters alone or in different combinations will be calculated with the aim of finding one or more tests with at least 90 sensitivityspecificity compared to liver biopsy
The objective of this study is to evaluate the diagnostic accuracy of non-invasive imaging techniques including US and MR methods in diagnosing NASH and fibrosis in patients with or at high risk of NAFLD using liver biopsy as the reference standard
Consecutive patients with a clinical indication for liver biopsy assessment of NAFLD are enrolled in this non-inferiority study They undergo both a liver ultrasound US including shear wave elastography SWE with liver stiffness measurement and US- fatty liver index US-FLI and a multiparametric unenhanced liver magnetic resonance examination including MR spectroscopy MRS Proton Density Fat Fraction PDFF and T2 measurement with Multiecho technique T1 mapping with Inversion Recovery method and Intravoxel Incoherent Motion diffusion weighted imaging IVIM-DWI measuring different parameters As reference standard histological diagnosis of fibrosis and steatohepatitis made according to the fatty liver inhibition of progression FLIP algorithm is used Sensitivity and specificity of imaging parameters alone or in different combinations will be calculated with the aim of finding one or more tests with at least 90 sensitivityspecificity compared to liver biopsy
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