Clinical trial · Interventional
Sonazoid Enhanced Liver Cancer Trial for Early Detection
NCT00822991CI-TRIAL-00004241unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B | — | UNRESOLVED | — |
| Hepatitis C | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B-mode US | Device | — | UNRESOLVED |
| CE-US (Sonazoid™) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group of CE-US
- description
- screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
- interventionNames
- Device: CE-US (Sonazoid™)
- type
- ACTIVE_COMPARATOR
- label
- Group of B-mode US
- description
- screening by conventional B-mode US every 3-5 months
- interventionNames
- Device: B-mode US
Primary outcomes (1)
- measure
- Size of HCC which is detected first
- timeFrame
- 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over 20 2. HBV or HCV related liver cirrhosis 3. No history of HCC 4. Diagnosed as liver cirrhosis histologically or clinically Histologically confirmed by liver biopsy Confirmed by formula of diagnosing cirrhosis Radiological finding Finding of portal hypertension Platelet\<130,000 5. Inpatient or outpatient 6. Patients who signed a written informed consent form Exclusion Criteria: 1. History of hypersensitivity to egg yolk 2. Pregnant or lactating women and women who may be pregnant 3. Severe liver dysfunction(AST, ALT,or BIL level \>10ULN 4. Associated with HCC 5. Patients receiving interferon 6. Age under 20 7. Judged by investigator not to be appropriate for inclusion in this study
References
Publications (1)
- DERIVEDKudo M, Hatanaka K, Kumada T, Toyoda H, Tada T. Double-contrast ultrasound: a novel surveillance tool for hepatocellular carcinoma. Am J Gastroenterol. 2011 Feb;106(2):368-70. doi: 10.1038/ajg.2010.432. No abstract available. PMID 21301463