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Ultrasound Index Fat Fraction (FAT-PLUS)

S

Supersonic Imagine

Status

Completed

Conditions

Steatosis of Liver

Treatments

Device: Echographic scan

Study type

Interventional

Funder types

Industry

Identifiers

NCT06373796
2024-A00523-44

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

88 participants in 1 patient group

FAT PLUS
Experimental group
Treatment:
Device: Echographic scan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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