Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC

Study Overview
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Brief Summary
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HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the tumor blood supply is not fully established, and there may be no typical manifestation on the image. In addition, atypical enhanced patterns caused by liver cirrhosis may also hinder imaging diagnosis of HCC. Therefore, early diagnosis of HCC in the context of cirrhosis remains a major clinical problem. Contrast-enhanced Ultrasound (CEUS) and MRI Contrast-enhanced Magnetic Resonance Imaging (CEMRI) are common diagnostic imaging methods. Till now, there is still lack of a detailed investigation comparing the diagnostic efficacies of CEUS and EOB-MRI for micro HCC in the context of cirrhosis. Therefore, this study aims to analyze the imaging patterns in CEUS and EOB-MRI for liver lesions with diameters ≤ 2 cm among patients with high risk of HCC, and to compare the diagnostic efficacies of EOB-MRI and CEUS for early-stage HCCs.

Official Title
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A Single-Center, Prospective Study Comparing the Diagnostic Efficiencies of Contrast-Enhanced Ultrasound and EOB Contrast-Enhanced Magnetic Resonance Imaging for Lesions With Diameters ≤ 2cm 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 CEUS and EOB-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are at high risk of HCC. The ages of patients are between 18 and 80. Patients are with solid liver lesion(s) ≤ 2 cm detected by imaging scan (US/CT/MRI). 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 CEUS and EOB-MRI<br>Patients with high risk of HCC having suspicious lesions with Diameters ≤ 2cm will receive CEUS and EOB-MRI examinations. | Diagnostic Test: Diagnostic CEUS and EOB-MRI<br>* Undergo Sonovue-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 CEUS and EOB-MRI | The sensitivity, specificity and accuracy of CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated. | 6 to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI | The sensitivity, specificity and accuracy of combined CEUS and EOB-MRI for liver lesion ≤ 2 cm will be calculated. | 6 to 12 months | 

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