Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

NCT04006275 — Phase 3, Unknown, 100 participants, Second Affiliated Hospital, Zhejiang University, School of Medicine

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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

Registry	NCT04006275
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, crossover, masking: triple, diagnostic
Enrollment	100 (Estimated)
Sponsor	Second Affiliated Hospital, Zhejiang University, School of Medicine (Other)
Conditions	Hepatocellular Carcinoma, Cirrhosis
Interventions	Sonovue and Sonazoid, Sonazoid and Sonovue (Drug)
Dates	start 2019-06-30, primary completion 2019-12-30 (estimated), completion 2019-12-30 (estimated), first posted 2019-07-05, last updated 2019-09-19
Locations	1 site in China

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Sonovue and Sonazoid Group	Experimental	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 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	Experimental	Drug: 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.

Sonovue and Sonazoid (Drug): 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 (Drug): 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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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)

Facility	City	Country	Status
Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University	Hangzhou, Zhejiang	China	Recruiting