Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD

NCT06662851 | Active Not Recruiting DMC

• 1 other identifier: ASANMC_UDFF
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the diagnostic utility of ultrasound-derived fat fraction (UDFF) in assessing hepatic steatosis in patients with suspected metabolic dysfunction-associated steatotic liver disease (MASLD). Using a prospective, cross-sectional design, the study will compare UDFF results with established diagnostic methods, including liver biopsy, MRI proton density fat fraction (PDFF), and controlled attenuation parameters (CAP) measurements. The ultimate goal is to determine if UDFF can serve as a non-invasive alternative to liver biopsy for diagnosing and staging hepatic steatosis, potentially reducing the need for invasive procedures in MASLD management.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

MASLD; Ultrasound; Steatosis; Liver Diseases; Fibrosis

Outcome Measures

Primary Outcomes (2)

• Correlation and agreement between UDFF and PDFF

  Spearman rank correlation coefficient Intraclass correlation coefficient (ICC) with a 2-way random effects model for absolute agreement Bland-Altman plots

  During procedure

• Diagnostic performance of UDFF for detecting and grading steatosis based on PDFF and histologic reference

  AUROC analysis

  During procedure

Secondary Outcomes (2)

• Intra-observer and inter-observer agreement

  During procedure

• UDFF performance in different fibrosis stages

  During procedure

Interventions

UDFF DIAGNOSTIC_TEST

Ultrasound-Derived Fat Fraction (UDFF) is a quantitative ultrasound technique used to assess hepatic steatosis by measuring the amount of fat in the liver tissue. UDFF estimates fat content using specific ultrasound parameters, namely the attenuation coefficient (AC) and backscatter coefficient (BSC). The AC measures the rate at which ultrasound waves weaken as they pass through the liver, which correlates with fat content, while the BSC quantifies the amount of reflected ultrasound signal, providing additional insights into liver tissue characteristics.

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suspected of MASLD, who are scheduled for pathologic exam such as liver biopsy or surgery

You may qualify if:

• Patients older than 18 and younger than 80 years
• Patients suspected of MASLD
• Patients who are planned to undergo either liver biopsy or surgery
• Patients willing to provide written informed consent.

You may not qualify if:

• Patients with a large tumor in Rt. hemiliver causing difficulty in performing UDFF measurement
• Patients with previous liver surgery or transplantation
• Patients with insufficient pathologic specimen for analysis of steatosis and fibrosis grade.
• Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with completing the study.

Sponsors & Collaborators

• So Yeon Kim: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pathological degree of hepatic steatosis and fibrosis

MeSH Terms

Conditions

Fatty Liver; Liver Diseases; Fibrosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: May 27, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 30, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)