Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

John McGahan, MD, University of California, Davis

ClinicalTrials.gov Identifier:

NCT00584402

First received: December 21, 2007

Last updated: December 19, 2012

Last verified: December 2012

History of Changes

Purpose

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	Intervention
Liver Neoplasms	Drug: perflutren lipid microspheres


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer Ultrasound

Drug Information available for: Perflutren

Genetic and Rare Diseases Information Center resources: Liver Cancer

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

estimation of the the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography [ Time Frame: 3 years ] [ Designated as safety issue: No ]


Enrollment:	8
Study Start Date:	April 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Contrast sonography Contrast-enhanced sonography	Drug: perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity Other Name: Definity

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584402

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

No publications provided


Responsible Party:	John McGahan, MD, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier:	NCT00584402 History of Changes
Other Study ID Numbers:	200715241
Study First Received:	December 21, 2007
Last Updated:	December 19, 2012
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by University of California, Davis:


liver cancer

Additional relevant MeSH terms:


Definity Perflutren Contrast Media Diagnostic Uses of Chemicals Pharmacologic Actions

ClinicalTrials.gov processed this record on March 02, 2015

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