Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC

NCT04006275 | Unknown Phase 3

• 1 other identifier: 研2019-073
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatocellular Carcinoma; Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 months

Study Arms (2)

Sonovue and Sonazoid Group

EXPERIMENTAL

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.

Drug: Sonovue and Sonazoid

Sonazoid and Sonovue Group

EXPERIMENTAL

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.

Drug: Sonazoid and Sonovue

Interventions

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.

Sonovue and Sonazoid Group

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.

Sonazoid and Sonovue Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at risk for HCC with focal liver lesion on conventional ultrasound.
• history of cirrhosis.
• historty of HBV infection.

You may not qualify if:

• systemic therapy with sorafenib
• pretreat lesion
• patients don't sign the informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 0571, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Fibrosis

Interventions

contrast agent BR1; Sonazoid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 5, 2019
• Study Start: June 30, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-06

Locations

CN (1)