Contrast-enhanced Ultrasound With Perfluorobutane and Sulfur Hexafluoride for Hepatocellular Carcinoma

Study Overview
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Brief Summary
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Intra-individual comparison of diagnostic performance of CEUS With perfluorobutane and sulfur hexafluoride for HCC in high-risk Individuals, and their role in the diagnostic algorithm of HCC.

Detailed Description
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The investigators would compare the diagnostic performance for HCC at high-risk individuals between both USG contrast agents.

Official Title
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Perfluorobutane-enhanced Ultrasound as a Diagnostic Tool for Hepatocellular Carcinoma in Individuals With High Risk: Intraindividual Comparison With Sulfur Hexafluoride-enhanced Ultrasound

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: contrast enhanced ultrasound
* Diagnostic Test: Dynamic CT
* Diagnostic Test: Liver MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: high-risk for HCC (liver cirrhosis, chronic hepatitis B) treatment-naive hepatic nodule (>= 1cm) on preceding CT, MR or ultrasound Exclusion Criteria: severe cardiopulmonary dysfunction pregnancy refusal to enroll study

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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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
Interventional Model Description: Study participants underwent contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride. The diagnostic performance will be compared intra-individually.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEUS with perfluorobutane and sulfur hexafluoride<br>Contrast-enhanced ultrasound with perfluorobutane and sulfur hexafluoride for the hepatic lesion. | Diagnostic Test: contrast enhanced ultrasound<br>* contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride<br>Diagnostic Test: Dynamic CT<br>* Participants underwent dynamic CT for hepatic lesion<br>Diagnostic Test: Liver MRI<br>* Participants underwent liver MRI for hepatic lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy for HCC: non-inferiority test | The per-lesion diagnostic accuracy for HCC of CEUS with perfluorobutane and sulfur hexafluoride using the same diagnostic criteria (arterial phase hyperenehancement with mild and late (≥ 60 sec) washout). | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of perfulorobutane enhanced USG using different definition of washout | Per-lesion sensitivity and specificity for diagnosing HCC using different time windows for assessing washout in PFB-US | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCC, Contrast-enhanced ultrasound, Perfluorobutane, Sulfur hexafluoride