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OpenTrials
Completed

NCT Number: NCT04462562

Quantitative US for Evaluation of Hepatic Steatosis in NAFLD

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.

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Key information

Conditions

Fatty Liver Digestive System Diseases Fatty Liver, Nonalcoholic Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

    Time frame: 1 month

    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 outcomes

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

    Time frame: 1 month

    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

  2. Correlation of QUS parameters and MR fat fraction

    Time frame: 1 month

    reference standard: MRI-PDFF or MR spectroscopy value (percent)

    • spearman's rank correlation of QUS parameters (TAI, TSI) values with MR fat fraction(percent)

  3. Intra-observer agreement of quantitative US parameters

    Time frame: 1 day

    Intraclass correlation coefficient (ICC), coefficient of variation (CV) of QUS parameter values (TAI value, TSI value)

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

    Time frame: 1 month

    pearson correlation coefficient (r) between estimated fat fraction and MRI-proton density fat fraction

  5. 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)

    Time frame: 1 month

    Reference standard: MRI-proton density fat fraction (10 percent, 15 percent, 20 percent, 20 percent)

  6. Diagnostic performance (area under the ROC curve (AUC)) of deep leraning model using QUS parametric maps for detection fatty liver (5 percent)

    Time frame: 1 month

    Reference standard: MRI-proton density fat fraction (5 percent)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Samsung Medison

Registry information

Official study title

The Diagnostic Performance Assessment of Quantitative Ultrasound Imaging Indices for Differentiating Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2020
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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