UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

Recruiting

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Diagnostic Test: UDFF

• Registration Number: NCT06080386
• Lead Sponsor: University Hospital, Angers

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-09-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Last Update Submitted: 2023-10-06
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Study Completion: 2023-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
one group	UDFF	Patients who had during their care UDFF ultrasound measurements and liver MRI over the study period may be included in this study

Primary Outcome Measures

Name	Time	Method
To evaluate the perfomances of the UDFF system for the quantification of hepatic steatosis in patients suspected of chronic hepatophyte.	3 months maximum between the 2 measurements (UDFF and MRi)	Steatosis value measured by multiecho sequences in MR

Trial Locations

Locations (1)

Angers university hospital; 🇫🇷 Angers, France