Sonazoid CEUS for Early HCC Surveillance

May 11, 2026 updated by: Tianjin Third Central Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

556

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300170
        • Tianjin Third Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sonazoid CEUS and US for screening
Sonazoid CEUS examination
Diagnostic test: Sonazoid CEUS
Sonazoid CEUS examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate
Time Frame: 3-year
To compare the detection rate of Sonazoid CEUS and US for early HCC
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Third Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • drjingxiang06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cirrhosis

Clinical Trials on Sonazoid CEUS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe