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Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

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ClinicalTrials.gov Identifier: NCT00584402
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Liver Neoplasms Drug: perflutren lipid microspheres

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

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
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren
U.S. FDA Resources

Arms and Interventions

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00584402     History of Changes
Other Study ID Numbers: 200715241
First Posted: January 2, 2008    Key Record Dates
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