Clinical trial · Interventional
Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis
Contrast-Enhanced Ultrasound Evaluation of Focal Liver Lesions in Patients With Cirrhosis or Other Risk Factors for Developing HCC
NCT03318380CI-TRIAL-00089887completedN/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)
This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamic Contrast-Enhanced Ultrasound Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic Contrast-Enhanced Ultrasound Imaging (CEUS)
- description
- Patients receive sulfur hexafluoride IV and undergo CEUS imaging over 10 minutes.
- interventionNames
- Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
Primary outcomes (4)
- measure
- Sensitivity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval 95% confidence interval for HCC diagnosis using CEUS LR-5 classification
- timeFrame
- Up to 12 months
- description
- A value of 67% for sensitivity is expected based on recent meta-analysis studies of CEUS for focal liver mass characterization.
- measure
- Specificity of contrast-enhanced ultrasound evaluation (CEUS) for diagnosis of Hepatocellular cancer using a 95% confidence interval
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Capable of making informed decisions regarding his/her treatment * Have known cirrhosis or other risk factors for HCC, based on American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) guidelines (applicable in each site jurisdictions) * Patients with untreated focal liver observations on liver ultrasound or multiphase contrast-enhanced CT or MRI performed as part of clinical standard of care within 4 weeks before patient enrollment. OR • Patients with untreated focal liver observations scheduled for follow-up multiphase contrast-enhanced CT or MRI, biopsy or surgical excision as part of clinical standard of care. CEUS should be performed within 4 weeks before or after follow-up imaging or within 4 weeks before biopsy or surgical excision. Exclusion Criteria: * Patients who are pregnant or lactating * Patients with focal liver observations less than 5 mm or greater than 5 cm in size * Patients with contraindications to CEUS * Patients with contraindications to both CT and MRI * Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable * Liver nodule previously treated with trans-arterial or thermal ablation * Patients who have received an investigational drug in the 30 days before CEUS, or will receive one within 72 hour after their CEUS exam
References
Publications (2)
- DERIVEDLyshchik A, Kuon Yeng Escalante C, Siu Xiao T, Piscaglia F, Kono Y, Medellin-Kowalewski A, Rodgers SK, Planz V, Kamaya A, Fetzer DT, Berzigotti A, Radu IP, Sidhu PS, Wessner CE, Bradigan K, Eisenbrey JR, Forsberg F, Wilson SR; CEUS LI-RADS Trial Group; CEUS LI-RADS Trial Group Members. Contrast-enhanced US of High-Risk Indeterminate Focal Liver Observations Categorized as LR-4 or LR-M at CT/MRI. Radiology. 2025 Jan;314(1):e240916. doi: 10.1148/radiol.240916. PMID 39835975
- DERIVEDKono Y, Piscaglia F, Wilson SR, Medellin A, Rodgers SK, Planz V, Kamaya A, Fetzer DT, Berzigotti A, Sidhu PS, Wessner CE, Bradigan K, Kuon Yeng Escalante CM, Siu Xiao T, Eisenbrey JR, Forsberg F, Lyshchik A; CEUS LI-RADS Trial Group. Clinical impact of CEUS on non-characterizable observations and observations with intermediate probability of malignancy on CT/MRI in patients at risk for HCC. Abdom Radiol (NY). 2024 Aug;49(8):2639-2649. doi: 10.1007/s00261-024-04305-9. Epub 2024 Jun 11. PMID 38860996