UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

Sponsor

University Hospital, Angers (Other)

Overall Status

Recruiting

CT.gov ID

NCT06080386

Collaborator

(none)

100

Enrollment

Location

19.5

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Diagnostic Test: UDFF

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 15, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Angers university hospital	Angers		France	49000

Sponsors and Collaborators

University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT06080386

Other Study ID Numbers:

202300122

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Oct 12, 2023