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OpenTrials
Active, Not Recruiting

NCT Number: NCT05855239

Quantification of Hepatic Steatosis With Different Ultrasound Frequency

The objective of this study is: (1) to compare the feasibility (technical successes rate and reliability) in measuring attenuation coefficient between two different frequencies (3MHz, 4MHz) of ultrasound beam; (2) to evaluate and compare the diagnostic performance of attenuation coefficient for steatosis using two different frequencies (3MHz, 4MHz) of ultrasound beam by comparison with the pathologic results acquired by liver biopsy or surgery.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan medical center

P’ungnap-tong, Seoul, 05505, South Korea

About this study

Investigators measure the distance between the skin and liver capsule on B-mod images.

Investigators place a region of interest (ROI) avoiding reverberation artifacts and acquire attenuation coefficient for five times.

For participants who require a liver biopsy, investigators try to target the same area in the liver, where ROI was placed.

Investigators evaluate hepatic steatosis, lobular inflammation, and fibrosis of tissue of the liver using a scoring system suggested by Nonalcoholic Steatohepatitis Clinical Research Network.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants who are candidates for liver donation and scheduled liver biopsies for assessment of hepatic steatosis
  • Participants suspected of nonalcoholic fatty liver disease and scheduled for liver biopsy or surgery

Exclusion criteria

  • Participants with a BMI of less than 23
  • Participants underwent liver transplantation or right hepatectomy
  • Participants who have a large mass in the right liver
  • Participants who have a bleeding tendency (platelet count < 80000, prothrombin time and international normalized ratio > 1.5)

Treatment and study plan

Primary outcomes

  1. Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging

    Time frame: During procedure

    dB/cm/MHz

  2. Percentage of fat within hepatocyte in pathological specimen

    Time frame: During procedure

    S0 (<5%), S1(5%~33%), S2(34%~66%), and S3 (>66%)

Sponsors and collaborators

Lead sponsor

Jong Keon Jang

Other

Collaborators

  • Canon Medical Systems, Korea

Registry information

Official study title

Quantification of Hepatic Steatosis in Patients With Fatty Liver Disease Using Attenuation Imaging With Different Ultrasound Frequency

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 11, 2023
Registry last updated
Aug 6, 2024

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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