Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Not Applicable

Completed

• Conditions: Liver Neoplasms
• Interventions: Drug: perflutren lipid microspheres

• Registration Number: NCT00584402
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-02
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2013-07-03
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-10
• Last Update Submitted: 2017-07-10
• Results First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast sonography	perflutren lipid microspheres	Contrast-enhanced sonography perflutren lipid microspheres

Primary Outcome Measures

Name	Time	Method
Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography	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 Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States