Skip to main content
OpenTrials
Completed

NCT Number: NCT06487325

A Clinical Study of Ultrasound-derived Fat Fraction to Assess Metabolic Dysfunction-Associated Steatotic Liver Disease

Aims: To evaluate the diagnostic performance of ultrasound-derived fat fraction (UDFF) in assessing the degree of hepatic steatosis in an obese population, with liver biopsy as reference standard.

Materials and methods: Obese individuals, who were found to have fatty liver by B-mode ultrasound and underwent UDFF measurement, along with liver biopsy results, were retrospectively selected from The First Affiliated Hospital of Shandong First Medical University.The inclusion criteria were as follows: (1) BMI over 30 kg/m²; (2) diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound; (3) serologic test results were available. The exclusion criteria include: (1) patients who have undergone liver resection or have liver space-occupying lesions; (2) pregnant women; (3) patients with incomplete medical history data.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

QianfoshanH

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI over 30 kg/m²
  • diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound
  • serologic test results were available

Exclusion criteria

  • patients who have undergone liver resection or have liver space-occupying lesions
  • pregnant women
  • patients with incomplete medical history data

Treatment and study plan

Primary outcomes

  1. UDFF values

    Time frame: up to 1 year

    During the examination, the DAX probe was positioned in the right intercostal space, and the UDFF mode was selected to place a fixed-size region of interest (ROI) vertically in the right lobe of the liver, 1.5 cm away from the liver capsule, avoiding the intrahepatic duct structure. Measurements were acquired after the patient maintained a calm breathing pattern, and the system automatically determined the shear wave velocity (Vs), elastic modulus (E), and UDFF values.

Secondary outcomes

  1. SWE values

    Time frame: up to 1 year

    The auto-SWE values were collected simultaneously when using UDFF mode, and the SWE and pSWE values were collected 10 times with 5C1 and DAX probes, respectively

Sponsors and collaborators

Lead sponsor

Ma Zhe

Other

Registry information

Official study title

Clinical Study of Ultrasound-derived Fat Fraction to Assess Metabolic Dysfunction-Associated Steatotic Liver Disease in Obese Population

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.