Quantitative Ultrasound for Diagnosing Hepatic Steatosis in Nonalcoholic Fatty Liver Multicenter Study

Quantitative Ultrasound Imaging Parameters for Hepatic Steatosis in Patients With Non-alcoholic Fatty Liver Disease: Multicenter Prospective Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04985188

Enrollment

112

Registered

2021-08-02

Start date

2021-08-12

Completion date

2022-12-31

Last updated

2021-08-02

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

Conditions

Diagnoses Disease

Brief summary

To evaluate the diagnostic performance of quantitative ultrasound parameters for assessing hepatic steatosis in non-alcoholic fatty liver disease using histologic results as reference standard

Interventions

DIAGNOSTIC_TESTQuantitative ultrasound (QUS) technique

Measurement of quantitative ultrasound parameter using clinical US machine (RS85)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD) * Patients who are scheduled hepatic parenchymal biopsy for suspected liver disease or hepatectomy for living donor liver donation * aged ≥ 18 years who are willing and able to complete all procedures

Exclusion criteria

* excessive alcohol consumption within 2 years (40g/day for men, 20g/day for women) * clinical, laboratory, or histologic evidence of a liver disease other than NAFLD, including viral hepatitis, autoimmune hepatitis, or genetic or acquired disorders * use of steatogenic or hepatotoxic medication * evidence of decompensated liver disease * history of liver surgery * any other condition believed by investigator to affect a patients' compliance, or completion of the study

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1)	1 month	Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result)

Secondary

Measure	Time frame	Description
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3)	1 month	Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S2 and S3)(reference standard: pathologic result)
Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH)	1 month	Evaluation of area under the ROC curve (AUC) for the detection of nonalcoholic steatohepatitis (reference standard: pathologic result)

Contacts

Primary ContactJeong Min Lee, MD

jmlshy2000@gmail.com02-2072-3107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026