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Validation of noninvasive multiparametric quantification of hepatic steatosis by ultrasound: A Prospective Single-Center Study

Validation of noninvasive multiparametric quantification of hepatic steatosis by ultrasound: A Prospective Single-Center Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128956
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic dysfunction-associated steatotic liver disease

Interventions

Index test:New Ultrasound-based Fat Fraction (UGFF) Technology

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older, with risk factors, clinical symptoms, or a prior diagnosis of steatotic liver disease (SLD), including previous imaging findings suggestive of steatosis, or elevated liver function tests accompanied by obesity or diabetes. 2. Have completed or are willing to undergo a liver MRI examination that complies with the technical specifications of this study before the ultrasound (US) examination, and to obtain quantitative proton density fat fraction (PDFF) data. 3. The interval between the ultrasound and MRI examinations should not exceed one month. 4. Able and willing to provide informed consent. 5. Able and willing to undergo a liver ultrasound examination, including fasting, breath-holding, and postural adjustments.

Exclusion criteria

Exclusion criteria: 1. Has advanced chronic liver disease (severe fibrosis; >F3). 2. Has a history of hepatocellular carcinoma or other primary or metastatic malignant liver tumors. 3. Has previously undergone liver surgery (excluding cholecystectomy), including wedge resection, lobectomy, or liver transplantation. 4. Is unable or unwilling to follow the instructions for MRI and ultrasound imaging. 5. Has severe artifacts on liver MRI or ultrasound images that affect the quality of quantitative measurements. 6. Has undergone abdominal surgery between the MRI and ultrasound examinations, or has started or stopped taking medications that may affect liver metabolism during that period. 7. Has experienced significant changes in body weight, diet, or alcohol intake between the MRI and ultrasound examinations.

Design outcomes

Primary

MeasureTime frame
Ultrasound examination data: Descriptive data of B-ultrasound images; Doppler measurement data; and quantitative measurement data of SWE and UGFF.;MRI PDFF examination data: MRI images and PDFF measurement results.;

Secondary

MeasureTime frame
Demographic information: Age, gender, ethnicity, relevant medical history and surgical history, including risk factors for liver disease and abdominal surgeries that affect the liver.;

Countries

China

Contacts

Public ContactRen Jie

The Third Affiliated Hospital Sun Yat-sen University

renjieguangzhou@126.com+86 20 85253048

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026