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Not yet recruiting NCT07590284

Sonazoid CEUS for Early HCC Surveillance

No phase Interventional Liver Cirrhosis Liver Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sonazoid CEUS.
Who it may be relevant to
Registry conditions: Liver Cirrhosis, Liver Fibrosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 test Sonazoid CEUS
    Sonazoid CEUS examination

Primary outcome measures

  • Detection rate [Time frame: 3-year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • Tianjin Third Central Hospital — Tianjin

Identifiers

NCT: NCT07590284 · drjingxiang06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗