Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Overview
- Phase
- Not Applicable
- Intervention
- perflutren lipid microspheres
- Conditions
- Liver Neoplasms
- Sponsor
- University of California, Davis
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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
Detailed Description
An estimated 75 patients (age 18 years of age or older) will be enrolled from the population of patients who present for ultrasound-guided radiofrequency ablation (RFA) of CT or MRI-confirmed multiple primary hepatocellular carcinoma (HCC) or metastatic carcinoma, with at least one of the tumors being ≤ 1.5 cm in diameter.
Investigators
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
Arms & Interventions
Contrast sonography
Contrast-enhanced sonography perflutren lipid microspheres
Intervention: perflutren lipid microspheres
Outcomes
Primary Outcomes
Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
Time Frame: 15 min
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
- 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(15 min)