NCT07590284

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

May 30, 2026

Expected
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2029

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

3.6 years

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Liver CirrhosisLiver Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Detection rate

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

    3-year

Study Arms (1)

Sonazoid CEUS and US for screening

OTHER

Sonazoid CEUS examination

Diagnostic Test: Sonazoid CEUS

Interventions

Sonazoid CEUSDIAGNOSTIC_TEST

Sonazoid CEUS examination

Sonazoid CEUS and US for screening

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300170, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 15, 2026

Study Start (Estimated)

May 30, 2026

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2029

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)