UDFF Performance Evaluation ((Ultrason Derived Fat Fraction) (UDFF)

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

Study Overview

• Status: Recruiting
• Conditions: Non Alcoholic Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: UDFF

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Christophe Aubé; Phone Number: +33 2 41 35 42 81; Email: chaube@chu-angers.fr
• Study Contact Backup: Name: Marie Bost; Phone Number: +33 2 41 35 31 99; Email: mabost@chu-angers.fr

Study Locations

• France
  • Angers, France, 49000
    • Recruiting
    • Angers University Hospital
    • Contact: Marie Bost; Phone Number: +33 2 41 35 31 88; Email: mabost@chu-angers.fr
    • Principal Investigator: Christophe Aubé

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients followed by the department of hepato gastroenterology of the CHU d'Angers for liver disease (NAFLD)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
one group; Patients who had during their care UDFF ultrasound measurements and liver MRI over the study period may be included in this study	Diagnostic test: UDFF; quantification of liver fat: UDFF (lipid fraction derived from ultrasound) from one of the probes of an ultrasound system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Estimated): October 15, 2023

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 202300122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No