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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:

Drug Information available for: Perflutren
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   (Adult, Senior)
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

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

ClinicalTrials.gov processed this record on September 23, 2016