Fatty Liver Clinical Trial
Official title:
Quantification of Hepatic Steatosis in Patients With Fatty Liver Disease Using Attenuation Imaging With Different Ultrasound Frequency
Verified date | June 2024 |
Source | Asan Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan medical center | P'ungnap-tong | Seoul |
Lead Sponsor | Collaborator |
---|---|
Jong Keon Jang | Canon Medical Systems, Korea |
Korea, Republic of,
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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