Quantification of Hepatic Steatosis With Different Ultrasound Frequency

Sponsor

Jong Keon Jang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05855239

Collaborator

Canon Medical Systems, Korea (Other)

120

Enrollment

Location

7.3

Anticipated Duration (Months)

16.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fatty Liver Fatty Liver, Nonalcoholic Ultrasound

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 22, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Attenuation coefficient (3MHz vs. 4MHz) in attenuating imaging [During procedure]
dB/cm/MHz
Percentage of fat within hepatocyte in pathological specimen [During procedure]
S0 (<5%), S1(5%~33%), S2(34%~66%), and S3 (>66%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)