Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

NCT ID: NCT00584402

Last Updated: 2017-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-03-31

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.

Conditions

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Liver Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Contrast sonography

Contrast-enhanced sonography perflutren lipid microspheres

Group Type EXPERIMENTAL

perflutren lipid microspheres

Intervention Type DRUG

perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity

Interventions

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perflutren lipid microspheres

perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity

Intervention Type DRUG

Other Intervention Names

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Definity

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John P. McGahan, M.D.

Role: PRINCIPAL_INVESTIGATOR

UC Davis School of Medicine Dept. of Radiology

Locations

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UC Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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200715241

Identifier Type: -

Identifier Source: org_study_id

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