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
1 other identifier
observational
112
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2021
CompletedFirst Posted
Study publicly available on registry
August 2, 2021
CompletedStudy Start
First participant enrolled
August 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 2, 2021
July 1, 2021
12 months
July 26, 2021
July 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S1)
Evaluation of area under the ROC curve (AUC) for the detection of fatty liver (S1)(reference standard: pathologic result)
1 month
Secondary Outcomes (2)
Diagnostic performance of quantitative ultrasound parameters for diagnosing hepatic steatosis (S2 and S3)
1 month
Diagnostic performance of quantitative ultrasound parameters for diagnosing nonalcoholic steatohepatitis (NASH)
1 month
Interventions
Measurement of quantitative ultrasound parameter using clinical US machine (RS85)
Eligibility Criteria
Clinically suspected or proven nonalcoholic fatty liver disease (NAFLD)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Ruijin Hospitalcollaborator
- Shenzhen Second People's Hospitalcollaborator
- Samsung Medisoncollaborator
Related Publications (1)
Huang TY, Li ZY, Tian J, Xie XJ, Lee JM, Ren XP, Xie XY. Metabolic Dysfunction-Associated Steatotic Liver Disease at Quantitative US: International Prospective Study. Radiology. 2025 Jul;316(1):e242564. doi: 10.1148/radiol.242564.
PMID: 40662970DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 26, 2021
First Posted
August 2, 2021
Study Start
August 12, 2021
Primary Completion
July 31, 2022
Study Completion
December 31, 2022
Last Updated
August 2, 2021
Record last verified: 2021-07