Evaluation of a Quantitative Ultrasound Model(DeepUSFF) for Liver Fat Quantification in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Multicenter Prospective Study Using MRI-PDFF as the Reference Standard

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This multicenter prospective study aims to evaluate the correlation between quantitative ultrasound fat fraction (USFF) and MRI-PDFF (Proton Density Fat Fraction) for liver fat quantification in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). The study will compare the diagnostic accuracy of quantitative ultrasound imaging against MRI-PDFF as the reference standard.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with clinically suspected MASLD based on abnormal ultrasound or liver function tests requiring liver ultrasound or MRI examination

• BMI ≥25 kg/m² or waist circumference \>90 cm (male) or \>80 cm (female), suggesting high likelihood of fatty liver disease

• Living liver transplant donors requiring preoperative liver ultrasound or MRI examination

• Age ≥18 years

• Understanding and signing informed consent

Locations
United States
Ohio
southwoods imaging (Northeastern Ohio Radiology Research and Education Fund )
RECRUITING
Boardman
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Jeong Min Lee, MD
jmsh@snu.ac.kr
+82-2-2072-3154
Backup
Eun Jung Choi, RN
eunjung0213@snu.ac.kr
+82-2-2072-4177
Time Frame
Start Date: 2025-06-24
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 62
Treatments
Experimental: Quantitative Ultrasound Fat Fraction Assessment
All enrolled participants undergo two non-invasive diagnostic imaging procedures within a 7-day window for direct comparison of liver fat quantification methods:~1. \*\*Quantitative Ultrasound Examination\*\*: Performed using Samsung RS85 ultrasound system with CA1-7S convex probe to obtain ultrasound fat fraction (DeepUSFF). The examination includes standard liver ultrasound assessment followed by quantitative fat fraction measurements in the right hepatic lobe (S5 or S8 segments). Multiple measurements (5 per session) are obtained during breath-holding to ensure reproducibility. Total examination time: approximately 10-15 minutes.~2. \*\*Non-contrast Liver MRI with PDFF\*\*: Magnetic resonance imaging with proton density fat fraction (MRI-PDFF) sequence and MR elastography performed within 7 days of the ultrasound examination. The MRI protocol includes breath-hold sequences (10-20 seconds each) for optimal image quality. Total examination time: approximately 15 minutes.
Related Therapeutic Areas
Sponsors
Collaborators: Northeastern Ohio Radiology Research and Education Fund
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov