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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05855239
Other study ID # ATI_Freq_01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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