Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04006275
• Other study ID #: ?2019-073
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cirrhosis
• Hepatocellular Carcinoma

Intervention

Drug:
• 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 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 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 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.

Locations

Country	Name	City	State
China	Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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