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Sonazoid CEUS for Early HCC Surveillance

A Multicenter, Prospective Study of Sonazoid CEUS for Early HCC Surveillance in a High-risk Population

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07590284
Enrollment
556
Registered
2026-05-15
Start date
2026-05-30
Completion date
2029-12-30
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Liver Fibrosis

Brief 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.

Interventions

DIAGNOSTIC_TESTSonazoid CEUS

Sonazoid CEUS examination

Sponsors

Tianjin Third Central Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. 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). 2. Age 18-80 years old. 3. Able to receive regular imaging, including US, CEUS, and CECT or CEMRI or EOB-MRI, according to the diagnostic and treatment procedures. 4. Obtained informed consent from the patient.

Exclusion criteria

1. Patients with pathologic or enhanced imaging of established HCC who have not undergone curative treatment. 2. Patients with known hypersensitivity to enhanced imaging contrast agents. 3. Patients with severe cardiac, pulmonary or renal insufficiency that precludes CECT or CEMRI or EOB-MRI. 4. Lactating and pregnant women. 5. Those who are not suitable for enrollment as assessed by the investigator. 6. Patients with egg or egg-product allergy, or with severe right-to-left cardiac shunt or intrapulmonary shunt.

Design outcomes

Primary

MeasureTime frameDescription
Detection rate3-yearTo compare the detection rate of Sonazoid CEUS and US for early HCC

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026