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NCT Number: NCT07590284

Sonazoid CEUS for Early HCC Surveillance

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Liver Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300170, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sonazoid CEUS

Diagnostic Test

Sonazoid CEUS examination

Primary outcomes

  1. Detection rate

    Time frame: 3-year

    To compare the detection rate of Sonazoid CEUS and US for early HCC

Sponsors and collaborators

Lead sponsor

Tianjin Third Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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