Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Liver Neoplasms	Drug: perflutren lipid microspheres	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	8 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Study Start Date :	April 2007
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	March 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Contrast sonography; Contrast-enhanced sonography perflutren lipid microspheres	Drug: perflutren lipid microspheres; perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity; Other Name: Definity

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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 [ Time Frame: 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:	John P. McGahan, M.D.	UC Davis School of Medicine Dept. of Radiology

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00584402 History of Changes
Other Study ID Numbers:	200715241
First Posted:	January 2, 2008
Results First Posted:	July 11, 2017
Last Update Posted:	July 11, 2017
Last Verified:	July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by University of California, Davis:

liver cancer

Additional relevant MeSH terms:

Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site	Neoplasms; Digestive System Diseases; Liver Diseases