Ultrasound Index Fat Fraction (FAT-PLUS)

June 30, 2025 updated by: SuperSonic Imagine

Comparison of the Ultrasound Index Fat Fraction (FAT PLUS) With the MRI-PDFF Score for Quantification of Hepatic Steatosis.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • CHU Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FAT PLUS
Device: Echographic scan
Liver ultrasound exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FAT PLUS
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SuperSonic Imagine

Investigators

  • Principal Investigator: Christophe Aubé, MD, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A00523-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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