Skip to content

Prospective multicenter clinical study of ultrasound derived fat fraction for assessing steatotic liver disease

Prospective multicenter clinical study of ultrasound derived fat fraction for assessing steatotic liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075194
Enrollment
Unknown
Registered
2023-08-29
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Steatotic liver disease

Interventions

Gold Standard:Pathology or MRI-PDFF
Index test: Ultrasound derived fat fraction

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: a. Adults aged =18 years old; b.Diffuse or heterogeneous fatty liver by conventional ultrasound; c. Meet the diagnostic criteria for SLD (Steatotic Liver Disease) established by international experts: diagnosed with hepatic steatosis through imaging or liver histology. This includes metabolic dysfunction-associated steatotic liver disease (MASLD), MASLD with a history of heavy alcohol intake (MetALD), other specific causes such as alcohol-induced, drug-induced, monogenic inherited SLD, and idiopathic SLD; d. Those planning to undergo liver histopathology examination or MRI-PDFF assessment of the degree of hepatic steatosis; e. Agree to participate in this study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: a. Age <18 years; b. Pregnant or breastfeeding women; c. No eligible liver histopathology examination or MRI-PDFF results prior to the examination, and unwillingness to cooperate with the relevant examinations after completing the UDFF examination. d. Liver transplant patients; e. Refusal to sign the written informed consent form.

Design outcomes

Secondary

MeasureTime frame
liver stiffness;

Primary

MeasureTime frame
Ultrasound derived fat fraction;ROC curve;accuracy;specificity;

Countries

China

Contacts

Public ContactWenwu Ling

West China Hospital of Sichuan University

lingwenwubing@163.com+86 189 8060 5569

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026