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CEUS with Sonazoid to Detect Small HCCs

Contrast-enhanced Ultrasound with Perfluorobutane (Sonazoid) to Detect Small Hepatocellular Carcinomas – A Prospective Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022389
Enrollment
Unknown
Registered
2019-04-09
Start date
2019-06-03
Completion date
Unknown
Last updated
2019-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma (HCC)

Interventions

Gold Standard:Histological findings or MRI features
Index test:Sonazoid-contrast&#32
ultrasound&#32
(S-CEUS)

Sponsors

Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients will be eligible for the study if they fulfill all of the followings criteria: 1) they are at least 18 years old; 2) with known chronic liver disease and liver cirrhosis; 3) On ultrasonography, their liver shows nodular liver parenchyma; 4) For chronic hepatitis B patients, their LSM-HCC score should be =11 (factors and scores please refer below) OR for other chronic liver diseases, the liver stiffness measurement (LSM) of the patients should be =12.0 kPa; and 5) All the patients must agree to participate in the study with informed written consent. Factors and their respective scores of LSM-HCC score (11) are listed below. 1. Age [>50 years, score +10] and [age 50 or less, score 0]; 2. Albumin [35g/l or less, score +1] and [albumin > 35g/l, score 0]; 3. HBV DNA [> 200,000 IU/ml, score +5] and [200,000 IU/ml or less, score 0]; 4. Liver stiffness measurement [8.0 kPa, score 0], [ 8.1-12.0 kPa, score +8] and [> 12.0 kPa, score +14]. *Total score ranges from 0 to 30. HBV = hepatitis B virus.

Exclusion criteria

Exclusion criteria: 1. Child-Pugh score 8 or above; 2. Previous or current hepatocellular carcinoma; 3. Portal vein thrombosis; 4. Previous liver surgery; 5. Liver transplantation; 6. Contraindications to transient elastography (e.g. pregnancy, previous pacemaker implantation); 7. Contraindications to Sonazoid contrast; 8. Contraindications to Primovist contrast; 9. Contraindications to magnetic resonance imaging (e.g. metallic implants, pacemaker implantation); 10. Refusal to consent.

Design outcomes

Primary

MeasureTime frame
detection of small HCC 2cm or smaller;

Secondary

MeasureTime frame
detection of HCC larger than 2.0cm;

Countries

China

Contacts

Public ContactCho Chi Min, Carmen

Prince of Wales Hospital, CUHK

ccm193@ha.org.hk+852 3505 1248

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026