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

So Yeon Kim

Status: Active, not recruiting

Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Treatments: Diagnostic Test: UDFF

Study type: Observational

Funder types: Other

Identifiers

NCT06662851

ASANMC_UDFF

Details and patient eligibility

About

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.

Full description

This prospective observational study, conducted at a single tertiary institution, will investigate the efficacy of ultrasound-derived fat fraction (UDFF) and point shear wave elastography (p-SWE) as non-invasive methods for quantifying liver fat content and fibrosis in patients scheduled for liver biopsy or surgery. The study will enroll 150 participants, suspected of MASLD and who are candidates for liver biopsy or resection.

The study will utilize Siemens ultrasound equipment to measure the UDFF using attenuation coefficient (AC) and backscatter coefficient (BSC) values for liver fat quantification. Additionally, TE parameters, such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM), will be recorded for comparison. The primary outcomes will assess UDFF's diagnostic accuracy against liver biopsy and MRI-PDFF. Secondary outcomes will include assessment of intra- and inter-observer variability, and correlations with patients' clinical data, such as BMI, liver fibrosis stages and liver function tests.

Expected benefits include validating UDFF as a reliable, non-invasive alternative for liver fat assessment, potentially reducing the need for invasive biopsies in managing liver disease.

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.