Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

Study Overview
=================
Brief Summary
-----------------
The new version of CEUS LI-RADS published at 2018(version 2017). In this study, the investigators aim to investigate the diagnosing performance of CEUS LI-RADS by administrating different contrast agents (SonoVue/ Sonazoid).

Detailed Description
-----------------
Independent radiologists from department of ultrasound will report their diagnosing results according to CEUS LI-RADS version 2017 without getting any information about patients. The researcher of this subject will collect all results and evaluated the sensitivity and specificity of CEUS LI-RADS and the diagnosing performance with different contrast agents.

Official Title
-----------------
Comparing SonoVue With Sonazoid in the Performance of Contrast Enhanced Ultrasound The Liver Imaging Reporting and Data System (CEUS-LIRADS) in Diagosing HCC: a Prospective Blind Study

Conditions
-----------------
Hepatocellular Carcinoma, Cirrhosis

Intervention / Treatment
-----------------
* Drug: Sonovue and Sonazoid
* Drug: Sonazoid and Sonovue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at risk for HCC with focal liver lesion on conventional ultrasound. history of cirrhosis. historty of HBV infection. Exclusion Criteria: systemic therapy with sorafenib pretreat lesion patients don't sign the informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: included patients receive both SonoVue and Sonazoid with a randomized crossover design. The wash out period is at least 30min to make sure the fore-inject contrast agent is clear in blood.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sonovue and Sonazoid Group<br>Subjects were randomized to receive SonoVue firstly and Sonazid secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at observing room for at least 30min. Contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio. | Drug: Sonovue and Sonazoid<br>* Subjects were randomized to receive SonoVue firstly and Sonazid secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at our department for at least 30min. contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio.<br>|
| Experimental: Sonazoid and Sonovue Group<br>Subjects were randomized to receive Sonazoid firstly and SonoVue secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at observing room for at least 30min. contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio. | Drug: Sonazoid and Sonovue<br>* Subjects were randomized to receive Sonazoid firstly and SonoVue secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at our department for at least 30min. contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients. | CEUS LI-RADS® v2017 which is published by ACR is a standardized system for technique, interpretation, reporting, and data collection for contrast-enhanced ultrasound exams in patients at risk for developing HCC. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of CEUS-LI-RADS by different contrast agencies. | The sensitivity and specificity are calculated using parameters such as ture postive, false positive, Ture negative, false negetive. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular Carcinoma, cirhossi, Contrast-enhanced ultrasound, LI-RADS