Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

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Primary Purpose

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Sonovue and Sonazoid

Sonazoid and Sonovue

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, cirhossi, Contrast-enhanced ultrasound, LI-RADS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Department of Ultrasound, The Second Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sonovue and Sonazoid Group

Sonazoid and Sonovue Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04006275

First Posted

June 25, 2019

Last Updated

September 17, 2019

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04006275

Brief Title

Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 30, 2019 (Actual)

Primary Completion Date

December 30, 2019 (Anticipated)

Study Completion Date

December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Cirrhosis

Keywords

Hepatocellular Carcinoma, cirhossi, Contrast-enhanced ultrasound, LI-RADS

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sonovue and Sonazoid Group

Arm Type

Experimental

Arm 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.

Arm Title

Sonazoid and Sonovue Group

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Sonovue and Sonazoid

Intervention 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 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

Intervention Name(s)

Sonazoid and Sonovue

Intervention 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 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.

Primary Outcome Measure Information:

Title

CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients.

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

The sensitivity and specificity of CEUS-LI-RADS by different contrast agencies.

Description

The sensitivity and specificity are calculated using parameters such as ture postive, false positive, Ture negative, false negetive.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Facility Information:

Facility Name

Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

0571

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pintong Huang, director

Phone

+8618857168333

Email

huangpintong@126.com

First Name & Middle Initial & Last Name & Degree

Chao Zhang, collegue

Phone

+8618888952277

Email

kuloncheung@163.com

Hepatocellular Carcinoma, Cirrhosis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial