Liver CirrhosisNCT07590284
Sonazoid CEUS for Early HCC Surveillance
A study testing Sonazoid CEUS in people with Liver Cirrhosis and Liver Fibrosis, run by Tianjin Third Central Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective study. In this study, enrolled subjects are cirrhotic patients of any etiology. The US and Sonazoid CEUS monitoring strategy was performed for cirrhotic patients: US and AFP joint with Sonazoid CEUS every 4 to 6 months, and combined CECT/CEMRI every 12 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Liver Fibrosis
- What is being tested?
- Sonazoid CEUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients diagnosed clinically or radiologically due to any etiology (patients with cirrhosis due to congenital fibrosis and patients with cirrhosis due to vascular causes were excluded).
- Age 18-80 years old.
- Able to receive regular imaging, including US, CEUS, and CECT or CEMRI or EOB-MRI, according to the diagnostic and treatment procedures.
- Obtained informed consent from the patient.
Who cannot join
- Patients with pathologic or enhanced imaging of established HCC who have not undergone curative treatment.
- Patients with known hypersensitivity to enhanced imaging contrast agents.
- Patients with severe cardiac, pulmonary or renal insufficiency that precludes CECT or CEMRI or EOB-MRI.
- Lactating and pregnant women.
- Those who are not suitable for enrollment as assessed by the investigator.
- Patients with egg or egg-product allergy, or with severe right-to-left cardiac shunt or intrapulmonary shunt.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170
About this study
Official title: A Multicenter, Prospective Study of Sonazoid CEUS for Early HCC Surveillance in a High-risk Population
This study is a multicenter, prospective study. In this study, enrolled subjects are cirrhotic patients of any etiology. The US and Sonazoid CEUS monitoring strategy was performed for cirrhotic patients: US and AFP joint with Sonazoid CEUS every 4 to 6 months, and combined CECT/CEMRI every 12 months.
- Conditions
- Liver Cirrhosis, Liver Fibrosis
- Being tested
- Sonazoid CEUS
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonazoid CEUSDiagnostic test
Sonazoid CEUS examination
| Study group | Role | What they receive |
|---|---|---|
| Sonazoid CEUS and US for screening | Other | Sonazoid CEUS examination Receives: Diagnostic Test: Sonazoid CEUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate
To compare the detection rate of Sonazoid CEUS and US for early HCC
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Third Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590284
- Sponsor's protocol ID
- drjingxiang06
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Study of Sonazoid CEUS for Early HCC Surveillance in a High-risk Population
- ClinicalTrials.gov ID
- NCT07590284
- Acronym / sponsor ID
- drjingxiang06
- Conditions
- Liver Cirrhosis, Liver Fibrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Tianjin Third Central HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 15 May 2026 (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.
This study is a multicenter, prospective study. In this study, enrolled subjects are cirrhotic patients of any etiology. The US and Sonazoid CEUS monitoring strategy was performed for cirrhotic patients: US and AFP joint with Sonazoid CEUS every 4 to 6 months, and combined CECT/CEMRI every 12 months.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonazoid CEUS and US for screening | Other | Diagnostic Test: Sonazoid CEUSSonazoid CEUS examination |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cirrhotic patients diagnosed clinically or radiologically due to any etiology (patients with cirrhosis due to congenital fibrosis and patients with cirrhosis due to vascular causes were excluded).
- Age 18-80 years old.
- Able to receive regular imaging, including US, CEUS, and CECT or CEMRI or EOB-MRI, according to the diagnostic and treatment procedures.
- Obtained informed consent from the patient.
Key exclusion criteria (6 listed)
- Patients with pathologic or enhanced imaging of established HCC who have not undergone curative treatment.
- Patients with known hypersensitivity to enhanced imaging contrast agents.
- Patients with severe cardiac, pulmonary or renal insufficiency that precludes CECT or CEMRI or EOB-MRI.
- Lactating and pregnant women.
- Those who are not suitable for enrollment as assessed by the investigator.
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 |
|---|---|---|
| Sonazoid CEUSSonazoid CEUS examination | Diagnostic test | Sonazoid CEUS and US for screening |
Primary outcome
Detection rate
Time frame: 3-year
To compare the detection rate of Sonazoid CEUS and US for early HCC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonazoid CEUS in people with Liver Cirrhosis and Liver Fibrosis, run by Tianjin Third Central Hospital 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 May 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate (time frame: 3-year). 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 15 May 2026.