Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Conditions
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Liver Neoplasms

Intervention / Treatment
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* Drug: perflutren lipid microspheres


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast sonography<br>Contrast-enhanced sonography perflutren lipid microspheres | Drug: perflutren lipid microspheres<br>* perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity<br>* Other names: Definity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography | 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. | 15 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type | 15 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cancer