Quantification of Hepatic Steatosis With Different Ultrasound Frequency

Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05855239
• Other study ID #: ATI_Freq_01
• Status: Active, not recruiting
• Start date: June 8, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Non-alcoholic Fatty Liver Disease
• Ultrasound

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	P'ungnap-tong	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Jong Keon Jang	Canon Medical Systems, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging	dB/cm/MHz	During procedure
Primary	Percentage of fat within hepatocyte in pathological specimen	S0 (<5%), S1(5%~33%), S2(34%~66%), and S3 (>66%)	During procedure