Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

NCT ID: NCT04006275

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-30

Study Completion Date

2019-12-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

included patients receive both SonoVue and Sonazoid with a randomized crossover design. The wash out period is at least 30min to make sure the fore-inject contrast agent is clear in blood.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The sequence of sonovue or sonazoid is blind to participant. The data is blind to the radiologist who is plan to evalutaed the data using CEUS LIRADS version 2017 and the outcome assessor who calculated all data and do the statistical calculation.

Study Groups

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Sonovue and Sonazoid Group

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.

Group Type EXPERIMENTAL

Sonovue and Sonazoid

Intervention Type 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 Group

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.

Group Type EXPERIMENTAL

Sonazoid and Sonovue

Intervention Type 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.

Interventions

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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.

Intervention Type 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 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Pintong Huang, director

Role: primary

+8618857168333

Chao Zhang, collegue

Role: backup

+8618888952277

Other Identifiers

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研2019-073

Identifier Type: -

Identifier Source: org_study_id

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