NCT06373796

Brief Summary

The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

April 16, 2024

Last Update Submit

June 30, 2025

Conditions

Steatosis of Liver

Outcome Measures

Primary Outcomes (1)

  • FAT PLUS

    The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis.

    3 months

Study Arms (1)

FAT PLUS

EXPERIMENTAL
Device: Echographic scan

Interventions

Echographic scanDEVICE

Liver ultrasound exam

FAT PLUS

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is ≥ 18 years old.
  • Subject is able to understand and sign the Informed Consent Form.
  • Subject is able to stand and walk independently.
  • Subject must have at least one or more routine ultrasound imaging procedures of the abdomen, at one of the participating study sites.
  • Subject must have at least one routine liver MRI with PDFF score performed within 30 days before or after the ultrasound examination
  • Subject is affiliated to National Social Insurance or a Health Insurance Regimen

You may not qualify if:

  • Subject is unable or unwilling to adhere to Study procedures
  • Subject is unable to understand the Informed Consent
  • Subject is unable to express its consent
  • Subject is under legal protection
  • Subject is deprived of liberty by judicial or administrative decision
  • Subject undergoes psychiatric treatment under constraint
  • Subject is pregnant or breastfeeding
  • Subject has latex allergy
  • Subject has an open wound, cut, and/or a rash which would preclude an ultrasound imaging procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Christophe Aubé, MD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 18, 2024

Study Start

June 6, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Locations

FR(1)