Role of CEUS as a Secondary Diagnostic Modality

Study Overview
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Brief Summary
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To determine the role of contrast-enhanced ultrasound (CEUS) as a second-line imaging modality after gadoxetate-enhanced MRI (Gd-EOB-MRI) for identifying hepatocellular carcinoma (HCC) among at-risks observations.

Detailed Description
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The purpose of our study was to evaluate the diagnostic ability of CEUS with perflubutane to identify HCC on the indeterminate observation in Gd-EOB-MRI and to establish the role of CEUS as a second-line (post-Gd-EOB-MRI) modality for HCC diagnosis.

Official Title
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Role of Sonazoid-enhanced Ultrasound as a Secondary Diagnostic Modality in Non-invasive Diagnostic Algorithms for Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: contrast enhanced ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at risk of HCC by Liver Imaging Reporting and Data System (LI-RADS) at least one treatment-naïve solid hepatic observation (≥1 cm) while surveillance using US, CT or MRI signed informed consent Exclusion Criteria: congestive hepatopathies severe cardiovascular dysfunction no recent cross-sectional images within 4 weeks suboptimal cross-sectional images quality

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants underwent CEUS. The image reviews based on cross-section images will be performed with or without CEUS results. Two image sets (cross-sectional image with CEUS and without CEUS) will be compared.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Cross-sectional image only<br>Image set which consists of a Cross-sectional image only. | |
| Active Comparator: Cross-sectional image with CEUS<br>The same participants with Arm1. But image set will consist of a Cross-sectional image and CEUS. | Diagnostic Test: contrast enhanced ultrasound<br>* Perflubutane enhanced ultrasound for evaluating hepatic tumor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared the image features of CEUS and Gd-EOB-MRI in at-risk observation | Compared the frequency of arterial phase hyperenhancement (APHE) and washout in at-risk observation, between CEUS and Gd-EOB-MRI. | 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks. | 
| Compared diagnostic performance of Gd-EOB-MRI alone and Gd-EOB-MRI with CEUS. | Evaluated sensitivity, specificity and accuracy for diagnose HCC by using Gd-EOB-MRI alone, or Gd-EOB-MRI with CEUS. | 1. For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. 2. The time interval between CEUS and Gd-EOB-MRI should not be exceed 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing image characters between two types of ultrasound contrast media | Comparing image characters between two types of ultrasound contrast media | For 3 days after undergoing CEUS to check the complication of CEUS, per each participants. |