N/A
N=8
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Liver Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00584402 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography — 8 tumor
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- perflutren lipid microspheres (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography |
8 | — |
| SECONDARY 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 |
8 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00584402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.