Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

Phase 3

• Conditions: Hepatocellular Carcinoma; Cirrhosis
• Interventions: Drug: Sonovue and Sonazoid; Drug: Sonazoid and Sonovue

• Registration Number: NCT04006275
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-25
• Study Start: 2019-06-30
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sonovue and Sonazoid Group	Sonovue and Sonazoid	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.
Sonazoid and Sonovue Group	Sonazoid and Sonovue	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.

Primary Outcome Measures

Name	Time	Method
CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients.	6 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China