Clinical trial NCT06662851: Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD
Official title: Usefulness of Ultrasound-derived Fat Fraction for Quantification of Hepatic Steatosis in Patients Suspected of MASLD: a Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Keywords: MASLD
Ultrasound
Steatosis
Liver Diseases
Fibrosis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected of MASLD, who are scheduled for pathologic exam such as liver biopsy or surgery

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation and agreement between UDFF and PDFF
timeFrame: During procedure
measure: Diagnostic performance of UDFF for detecting and grading steatosis based on PDFF and histologic reference
timeFrame: During procedure
Secondary outcomes:
measure: Intra-observer and inter-observer agreement
timeFrame: During procedure
measure: UDFF performance in different fibrosis stages
timeFrame: During procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
References: