NCT06080386

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

October 6, 2023

Last Update Submit

October 6, 2023

Conditions

Non Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

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

Interventions

UDFFDIAGNOSTIC_TEST

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

one group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers university hospital

Angers, 49000, France

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Central Study Contacts

Christophe Aubé

CONTACT

+33 2 41 35 42 81chaube@chu-angers.fr

Marie Bost

CONTACT

+33 2 41 35 31 99mabost@chu-angers.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 12, 2023

Study Start

March 1, 2022

Primary Completion

September 1, 2023

Study Completion

October 15, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)