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Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma Cirrhosis | Drug: Sonovue and Sonazoid Drug: Sonazoid and Sonovue | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention 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: | Triple (Participant, Investigator, Outcomes 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. |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | June 30, 2019 |
| Estimated Primary Completion Date : | December 30, 2019 |
| Estimated Study Completion Date : | December 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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. |
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 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. |
|
Experimental: 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. |
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. |
- CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients. [ Time Frame: 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.
- The sensitivity and specificity of CEUS-LI-RADS by different contrast agencies. [ Time Frame: 6 months ]The sensitivity and specificity are calculated using parameters such as ture postive, false positive, Ture negative, false negetive.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| China, Zhejiang | |
| Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University | Recruiting |
| Hangzhou, Zhejiang, China, 0571 | |
| Contact: Pintong Huang, director +8618857168333 huangpintong@126.com | |
| Contact: Chao Zhang, collegue +8618888952277 kuloncheung@163.com | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 25, 2019 | ||||
| First Posted Date ICMJE | July 5, 2019 | ||||
| Last Update Posted Date | September 19, 2019 | ||||
| Actual Study Start Date ICMJE | June 30, 2019 | ||||
| Estimated Primary Completion Date | December 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients. [ Time Frame: 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
The sensitivity and specificity of CEUS-LI-RADS by different contrast agencies. [ Time Frame: 6 months ] The sensitivity and specificity are calculated using parameters such as ture postive, false positive, Ture negative, false negetive.
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC | ||||
| Official Title ICMJE | 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 | ||||
| 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Intervention 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: Triple (Participant, Investigator, Outcomes 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. Primary Purpose: Diagnostic
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 30, 2019 | ||||
| Estimated Primary Completion Date | December 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04006275 | ||||
| Other Study ID Numbers ICMJE | 研2019-073 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Study Sponsor ICMJE | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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