Quantification of Hepatic Steatosis With Different Ultrasound Frequency

NCT05855239 | Active Not Recruiting DMC

• 1 other identifier: ATI_Freq_01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatty Liver; Fatty Liver, Nonalcoholic; Ultrasound

Keywords

Hepatic steatosis; Quantification; Ultrasound; Attenuation coefficient

Outcome Measures

Primary Outcomes (2)

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

  dB/cm/MHz

  During procedure

• Percentage of fat within hepatocyte in pathological specimen

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

  During procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants at risk of fatty liver disease

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jong Keon Jang: lead
• Canon Medical Systems, Korea: collaborator

Study Sites (1)

Asan medical center

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

Location

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• JongKeon Jang, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 11, 2023
• Study Start: June 8, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)