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NCT06080386 Clinical Trial

UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

Non Alcoholic Fatty Liver Disease Clinical Trial

— UDFF  

Official title:
UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06080386
Other study ID # 202300122
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date October 15, 2023

Study information
Verified date October 2023
Source University Hospital, Angers
Contact Christophe Aubé
Phone +33 2 41 35 42 81
Email chaube@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess UDFF performance (compared to MRI)

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date October 15, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients who had hepatic ultrasound with available UDFF measurements and hepatic MRI (with steatosis quantification sequences) between 01/01/2022 and 31/09/2023 may be included. Exclusion Criteria: - chronic liver disease with a different etiology other than NAFL/NASH or mixed (hepatitis B or C, hemochromatosis, autoimmune hepatitis, Wilson's disease, cholestasic disease, alpha 1 antitrypsin deficiency), - decompensated cirrhosis (ascites, jaundice, encephalopathy, rupture of esophageal varices), - hepatocellular carcinoma. - opposition to the use of its data

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• UDFF
quantification of liver fat: UDFF (lipid fraction derived from ultrasound) from one of the probes of an ultrasound system

Locations
Country Name City State
France Angers university hospital Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the perfomances of the UDFF system for the quantification of hepatic steatosis in patients suspected of chronic hepatophyte. Steatosis value measured by multiecho sequences in MR 3 months maximum between the 2 measurements (UDFF and MRi)
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