Hepatocellular CarcinomaPhase 3NCT04006275
Comparing SonoVue With Sonazoid Using CEUS-LIRADS in HCC
A Phase 3 study testing Sonovue and Sonazoid and Sonazoid and Sonovue in people with Hepatocellular Carcinoma and Cirrhosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Cirrhosis
- What is being tested?
- Sonovue and Sonazoid and Sonazoid and Sonovue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2019to 30 Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at risk for HCC with focal liver lesion on conventional ultrasound.
- history of cirrhosis.
- historty of HBV infection.
Who cannot join
- systemic therapy with sorafenib
- pretreat lesion
- patients don't sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 0571
Pintong Huang, director, +8618857168333, huangpintong@126.com
Chao Zhang, collegue, +8618888952277, kuloncheung@163.com
About this study
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
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).
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Cirrhosis
- Being tested
- Sonovue and Sonazoid, Sonazoid and Sonovue
- Keywords
- Hepatocellular Carcinoma, cirhossi, Contrast-enhanced ultrasound, LI-RADS
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonovue and SonazoidDrug
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 SonovueDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sonazoid and Sonovue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start30 Jun 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006275
- Sponsor's protocol ID
- 研2019-073
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04006275
- Acronym / sponsor ID
- 研2019-073
- Conditions
- Hepatocellular Carcinoma, Cirrhosis
- Keywords
- Hepatocellular Carcinoma, cirhossi, Contrast-enhanced ultrasound, LI-RADS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sonovue and Sonazoid Group | Experimental | Drug: Sonovue and SonazoidSubjects 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. |
| Sonazoid and Sonovue Group | Experimental | Drug: Sonazoid and SonovueSubjects 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients at risk for HCC with focal liver lesion on conventional ultrasound.
- history of cirrhosis.
- historty of HBV infection.
Key exclusion criteria (3 listed)
- systemic therapy with sorafenib
- pretreat lesion
- patients don't sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonovue and SonazoidSubjects 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. | Drug | Sonovue and Sonazoid Group |
| Sonazoid and SonovueSubjects 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. | Drug | Sonazoid and Sonovue Group |
Primary outcome
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.
1 secondary outcome
The sensitivity and specificity of CEUS-LI-RADS by different contrast agencies.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sonovue and Sonazoid and Sonazoid and Sonovue in people with Hepatocellular Carcinoma and Cirrhosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CEUS LI-RADS Grades of SonoVue and Sonazoid agents in enrolled patients. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.