An observational study in MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, sponsored by So Yeon Kim. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by So Yeon Kim · Observational
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.
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.
1,462 studies on the registry are indexed under Fatty Liver; 289 are open to participants now.
This study's planned enrollment of 150 is close to the median of 140 across 402 observational studies indexed under Fatty Liver.
Browse Fatty Liver studies →So Yeon Kim is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Patients suspected of MASLD, who are scheduled for pathologic exam such as liver biopsy or surgery
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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.
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
Time frame: During procedure
Diagnostic performance of UDFF for detecting and grading steatosis based on PDFF and histologic reference
AUROC analysis
Time frame: During procedure
Intra-observer and inter-observer agreement
Intraclass correlation coefficient
Time frame: During procedure
UDFF performance in different fibrosis stages
Subgroup analysis according to different fibrosis stages
Time frame: During procedure
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Jun 2025, 12 months after the start.
Of 142 non-industry observational studies under Fatty Liver, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 122. This study's planned 12 months is below that.
Counting every sponsor, half of 152 studies reached it within 39 months; a quarter within 20 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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So Yeon Kim