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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04985188

Collaborator

First Affiliated Hospital, Sun Yat-Sen University (Other), Ruijin Hospital (Other), Shenzhen Second People's Hospital (Other), Samsung Medison (Industry)

112

Enrollment

16.6

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diagnoses Disease	Diagnostic Test: Quantitative ultrasound (QUS) technique

Study Design

Study Type:

Observational

Anticipated Enrollment :

112 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 12, 2021

Anticipated Primary Completion Date :

Jul 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul National University Hospital
First Affiliated Hospital, Sun Yat-Sen University
Ruijin Hospital
Shenzhen Second People's Hospital
Samsung Medison

Investigators

Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Min Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04985188

Other Study ID Numbers:

2102-159-1199

First Posted:

Aug 2, 2021

Last Update Posted:

Aug 2, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatty Liver

Study Results

No Results Posted as of Aug 2, 2021