Clinical trial · Interventional
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
NCT00584402CI-TRIAL-00028544completedN/AResults postedClinicalTrials.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 purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas \& metastases) within the liver. Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography
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 Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| perflutren lipid microspheres | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast sonography
- description
- Contrast-enhanced sonography perflutren lipid microspheres
- interventionNames
- Drug: perflutren lipid microspheres
Primary outcomes (1)
- measure
- Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
- timeFrame
- 15 min
- description
- After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.
Secondary outcomes (1)
- measure
- Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment * Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter * Patient is stable and is to be managed conservatively (i.e. non-surgically) * 18 years of age or older * Ability and willingness to provide written informed consent Exclusion Criteria: * Known or suspected cardiac shunt(s) * Known sensitivity to octafluoropropane * Pregnant or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.