Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC

Study Overview
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Brief Summary
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Hepatocellular carcinoma (HCC) is the fifth most common cancer. Patients with HCCs usually have a poor prognosis. Hepatocarcinogenesis is an intricate and multistep process. Detecting and staging early HCC in patients with liver cirrhosis are still challenging for imaging techniques. Contrast-enhanced ultrasonography (CEUS) and gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) are widely used in clinical practice. EOB-MRI has advantages of high detecting rate for small lesions, high sensitivity of hepatobiliary phase and extensive image information. Sonazoid has the advantage of offering a unique post-vascular phase, also called the Kupffer phase. Therefore, malignant tumors with few or no Kupffer cells appear as contrast defects, with respect to the relatively well-enhanced surrounding liver in the postvascular phase. The diagnostic efficacies of these two imaging methods have not been well studied. Therefore, the purpose of this study is to compare the efficacies of Sonazoid-CEUS and EOB-MRI in patients with high risk of HCC, and to compare the detection ability for malignant tumors by Kupffer phase and hepatobiliary phase.

Official Title
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A Single-center, Prospective Controlled Study of the Diagnostic Efficacies of Sonazoid-CEUS and EOB-MRI in Patients With High Risk of HCC

Conditions
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Hepatocellular Cancer, Liver Cirrhoses, Diagnoses Disease

Intervention / Treatment
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* Diagnostic Test: Diagnostic Sonazoid-CEUS and EOB-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are at high risk for HCC. The ages of patients are between 18 and 80. Patients are with solid liver lesion(s) detected by US: if a patient has a solitary tumor, the size of the tumor is less than or equal to 5 cm; if a patient has multiple lesions, the sizes of the tumors are less than or equal to 3 cm and the number of lesions is less than or equal to 3. Patient is able and willing to receive CEUS and EOB-MRI examinations within 30 days. Patient signs the informed consent. - Exclusion Criteria: Patient is with lesions confirmed by pathology or follow-up, or hemangiomas. Patient is with lesions already undergoing local treatment, including thermal ablation or TACE. Patient is with severe cardiopulmonary insufficiency. Patient is a pregnant or breastfeeding women. Patient is considered to be unsuitable to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic Sonazoid-CEUS and EOB-MRI<br>Patients with high risk of HCC having suspicious lesions on US will receive Sonazoid-CEUS and EOB-MRI examinations. | Diagnostic Test: Diagnostic Sonazoid-CEUS and EOB-MRI<br>* Undergo Sonazoid-CEUS and EOB-MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI | The sensitivity, specificity and accuracy of Sonazoid-CEUS and EOB-MRI in the diagnosis for patients with high risk of HCC will be determined. | 6 to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection rate of the additionally found HCC | The detection rate of the additionally found HCC on Sonazoid-CEUS and EOB-MRI will be determined . | 6 to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Sonazoid Contrast-enhanced ultrasound, EOB-MRI, Diagnostic Efficacy