Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

Zhejiang University

Status and phase: Unknown; Phase 3

Conditions: Cirrhosis; Hepatocellular Carcinoma

Treatments: Drug: Sonovue and Sonazoid; Drug: Sonazoid and Sonovue

Study type: Interventional

Funder types: Other

Identifiers

NCT04006275

研2019-073

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Sonovue and Sonazoid Group

Experimental group

Description:

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.

Treatment:

Drug: Sonovue and Sonazoid

Sonazoid and Sonovue Group

Experimental group

Description:

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.

Treatment:

Drug: Sonazoid and Sonovue