Comparing quantitative ultrasound (DeepUSFF) and MRI to measure liver fat in MASLD
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
The team will test whether a faster, lower-cost ultrasound method called DeepUSFF can match MRI-PDFF for measuring liver fat in adults with MASLD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 2 sites (Boardman, Ohio and 1 other locations) |
| Trial ID | NCT07192159 on ClinicalTrials.gov |
What this trial studies
This is a prospective multicenter study enrolling 62 adults suspected of having MASLD to compare quantitative ultrasound fat fraction (DeepUSFF) with MRI-PDFF. Each participant will undergo both a quantitative ultrasound examination and a non-contrast liver MRI within one week. The primary outcome is the correlation coefficient between DeepUSFF and MRI-PDFF; secondary outcomes include diagnostic accuracy measures and inter-observer reproducibility. The study includes participants across different ethnicities and degrees of hepatic steatosis to test generalizability.
Who should consider this trial
Good fit: Adults (age ≥18) with suspected MASLD—such as those with abnormal liver tests or imaging, BMI ≥25 kg/m² or central obesity, or living liver donor candidates—who can undergo both ultrasound and MRI and provide informed consent.
Not a fit: People with other chronic liver diseases (positive HBV or HCV markers), decompensated liver failure, recent heavy alcohol use, prior liver cancer or major liver surgery, or other excluded conditions are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, DeepUSFF could offer a quicker, lower-cost, and more widely available way to measure liver fat without relying on MRI or invasive biopsy.
How similar studies have performed: Previous work with quantitative ultrasound methods has shown promising correlation with MRI-PDFF, but DeepUSFF requires prospective multicenter validation to confirm those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Significant alcohol consumption in the past 2 years: Male: ≥30-60g/day average alcohol intake Female: ≥20-50g/day average alcohol intake -Chronic liver disease: Histological diagnosis of chronic liver disease HBsAg positive Anti-HCV positive Other suspected chronic liver diseases -Liver failure: Serum albumin \<3.2 g/dL INR \>1.3 Direct bilirubin \>1.3 mg/dL * History of esophageal varices, ascites, hepatic encephalopathy, or acute biliary obstruction * History of liver cancer diagnosis or treatment * History of liver surgery * Pregnancy * Inability to obtain adequate liver ultrasound imaging: Patient cooperation impossible Inadequate image acquisition as determined by investigator -Inability to obtain adequate liver MRI imaging: Patient cooperation impossible Severe obesity preventing MRI examination MRI contraindications (cardiac pacemaker, etc.) Other factors preventing adequate imaging as determined by investigator
Where this trial is running
Boardman, Ohio and 1 other locations
- southwoods imaging (Northeastern Ohio Radiology Research and Education Fund ) — Boardman, Ohio, United States (Recruiting)
- Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Jeong Min Lee, MD — Seoul National University Hospital
- Study coordinator: Jeong Min Lee, MD
- Email: jmsh@snu.ac.kr
- Phone: +82-2-2072-3154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.