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
  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:


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
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:
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 14, 2014