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Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

Primary Purpose

Fatty Liver, Fatty Liver, Nonalcoholic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quantitative US (Samsung Medison, RS85A)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fatty Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

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
  • contraindication to MRI
  • any other condition believed by investigator to affect a patients' compliance, or completion of the study

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

quantitative ultrasound imaging parameters

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)
Reference standard: MRI-PDFF or MR spectroscopy value (10 percent, 15 percent, 15 percent, 20 percent, 25 percent) - ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >10, >20 percent patients
Correlation of QUS parameters and MR fat fraction
reference standard: MRI-PDFF or MR spectroscopy value (percent) - spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent)
Intra-observer agreement of quantitative US parameters
Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value)
Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction
pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction
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)
Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 20 percent)
Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)
Reference standard: MRI-proton density fat fraction (5 percent)

Full Information

First Posted
March 31, 2020
Last Updated
March 3, 2022
Sponsor
Seoul National University Hospital
Collaborators
Samsung Medison
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1. Study Identification

Unique Protocol Identification Number
NCT04462562
Brief Title
Quantitative US for Evaluation of Hepatic Steatosis in NAFLD
Official Title
The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Samsung Medison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Fatty Liver, Nonalcoholic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quantitative ultrasound imaging parameters
Arm Type
Experimental
Arm Description
quantitative ultrasound imaging parameters tissue attenuation imaging (TAI) parameter tissue scatter-distribution imaging (TSI) parameter Hepatorenal index (semi-auto, EzHRI)
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitative US (Samsung Medison, RS85A)
Intervention Description
In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed
Primary Outcome Measure Information:
Title
Diagnostic performance (area under the ROC curve (AUC)) of quantitative US (QUS) parameters (TAI, TSI) for detection of fatty liver (MRI-PDFF 5 percent)
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Diagnostic performance (area under the ROC curve (AUC)) of QUS parameters (TAI, TSI) for detection of moderate fatty liver (MRI-PDFF 10, 20 percent)
Description
Reference standard: MRI-PDFF or MR spectroscopy value (10 percent, 15 percent, 15 percent, 20 percent, 25 percent) - ROC curve analysis of each QUS parameters (TAI, TSI, EzHRI) for the detection of MRI-PDFF >10, >20 percent patients
Time Frame
1 month
Title
Correlation of QUS parameters and MR fat fraction
Description
reference standard: MRI-PDFF or MR spectroscopy value (percent) - spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent)
Time Frame
1 month
Title
Intra-observer agreement of quantitative US parameters
Description
Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value)
Time Frame
1 day
Title
Correlation between estimated fat fraction from deep learning model and MRI-proton density fat fraction
Description
pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction
Time Frame
1 month
Title
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)
Description
Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 20 percent)
Time Frame
1 month
Title
Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)
Description
Reference standard: MRI-proton density fat fraction (5 percent)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 contraindication to MRI any other condition believed by investigator to affect a patients' compliance, or completion of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

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