Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation



Status:Completed
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/12/2017
Start Date:April 2007
End Date:March 2009

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Trial Summary
Trial Overview
Inclusion Criteria
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

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.

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
We found this trial at
1
site
UC Davis Medical Center
Sacramento, California 95814
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Sacramento, CA
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