Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

Second Affiliated Hospital, School of Medicine, Zhejiang University100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

100

Conditions

Hepatocellular Carcinoma Cirrhosis

Interventions

Sonovue and SonazoidDRUG

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.

Sonazoid and SonovueDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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