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

NCT ID: NCT04985188

Last Updated: 2021-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-12

Study Completion Date

2022-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Diagnoses Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Quantitative ultrasound (QUS) technique

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

Samsung Medison

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Central Contacts

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Jeong Min Lee, MD

Role: CONTACT

02-2072-3107

References

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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.

Reference Type DERIVED
PMID: 40662970 (View on PubMed)

Other Identifiers

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2102-159-1199

Identifier Type: -

Identifier Source: org_study_id

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