None listed
Conditions
Interventions
None listed
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals at high risk for hepatocellular carcinoma (HCC), including those with chronic hepatitis B, a history of HCC, or liver cirrhosis. 2. Detection of a liver lesion =1 cm during HCC surveillance, diagnosed as probable HCC or an indeterminate nodule on first-line imaging (CT or MRI). 3. Provided written informed consent after receiving a full explanation of the study. 4. Age 19 years or older at the time of consent. 5. Liver MRI performed within one month prior to the CEUS examination.
Exclusion criteria
Exclusion criteria: 1. History of malignancy other than HCC (except for early-stage solid organ cancers such as early gastric or thyroid cancer with no recurrence for at least 5 years). 2. Recurrence at a previously treated site of HCC. 3. Absolute contraindications to Sonazoid, including hypersensitivity to the drug or any of its components, right-to-left shunt, severe pulmonary hypertension, or severe respiratory distress. 4. Pregnant or breast-feeding individuals. 5. Egg allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of diagnostic accuracy between CEUS LI-RADS 2017 and modified CEUS LI-RADS using Sonazoid contrast-enhanced ultrasonography for HCC diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of sensitivity and specificity for HCC diagnosis between CEUS LI-RADS 2017 and modified CEUS LI-RADS criteria applied to Sonazoid CEUS.;Comparison of false negative rates in HCC diagnosis between Gd-EOB-MRI alone and Gd-EOB-MRI followed by Sonazoid CEUS. | — |
Countries
Korea, Republic of
Contacts
Public ContactJeonghyun Kim
Samsung Medical Center
Outcome results
None listed