Sonazoid CEUS for Early HCC Surveillance | NCT07590284

Studies
Sonazoid CEUS for Early HCC Surveillance

NCT07590284

Sponsor

Tianjin Third Central Hospital

Status

Not yet recruiting

Last Update Posted

May 15, 2026Actual

Enrollment

556Estimated

Phase

Not Applicable

Conditions

Liver Cirrhosis
Liver Fibrosis

Interventions

Sonazoid CEUS

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2026Estimated

Primary Completion Date

Dec 30, 2029Estimated

Completion Date

Dec 30, 2029Estimated

First Submitted Date

May 11, 2026

First Submission Date that Met QC Criteria

May 11, 2026

First Posted Date

May 15, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

556Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sonazoid CEUS and US for screening	Other	Sonazoid CEUS examination	Diagnostic Test: Sonazoid CEUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sonazoid CEUS	Diagnostic Test	Sonazoid CEUS examination	Sonazoid CEUS and US for screening

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Third Central Hospital		Tianjin	Tianjin Municipality	300170	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided