NCT04462562

Brief Summary

The purpose of this study is to evaluate diagnostic performance of quantitative ultrasonographic parameters for the assessment of hepatic steatosis with find optimal cut-off values in patients with non-alcoholic fatty liver disease using magnetic resonance imaging proton density fat fraction (MRI-PDFF) and MR spectroscopy as the reference standard.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

March 31, 2020

Last Update Submit

March 3, 2022

Conditions

Fatty LiverFatty Liver, Nonalcoholic

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)

    Reference standard: MRI-proton density fat fraction or MR spectroscopy value (5 percent) \- ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF \>5 percent patients

    1 month

Secondary Outcomes (6)

  • Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)

    1 month

  • Correlation of QUS parameters and MR fat fraction

    1 month

  • Intra-observer agreement of quantitative US parameters

    1 day

  • Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction

    1 month

  • Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (10 percent, 15 percent, 15 percent, 20 percent)

    1 month

  • +1 more secondary outcomes

Study Arms (1)

quantitative ultrasound imaging parameters

EXPERIMENTAL

quantitative ultrasound imaging parameters * tissue attenuation imaging (TAI) parameter * tissue scatter-distribution imaging (TSI) parameter * Hepatorenal index (semi-auto, EzHRI)

Diagnostic Test: Quantitative US (Samsung Medison, RS85A)

Interventions

Quantitative US (Samsung Medison, RS85A)DIAGNOSTIC_TEST

In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed

quantitative ultrasound imaging parameters

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with known NAFLD or suspected of having NAFLD
  • Patients who are scheduled 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
  • contraindication to MRI
  • 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

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Jeon SK, Lee JM, Joo I, Yoon JH, Lee G. Two-dimensional Convolutional Neural Network Using Quantitative US for Noninvasive Assessment of Hepatic Steatosis in NAFLD. Radiology. 2023 Apr;307(1):e221510. doi: 10.1148/radiol.221510. Epub 2023 Jan 3.

    PMID: 36594835DERIVED

MeSH Terms

Conditions

Fatty LiverNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Jeong Min Lee

    Seoul National University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2020

First Posted

July 8, 2020

Study Start

July 3, 2020

Primary Completion

June 29, 2021

Study Completion

June 29, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

KR(1)