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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

December 21, 2007
December 19, 2012
April 2007
March 2009   (final data collection date for primary outcome measure)
estimation of the the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00584402 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

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

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Liver Neoplasms
Drug: perflutren lipid microspheres
IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Other Name: Definity
Experimental: Contrast sonography
Contrast-enhanced sonography
Intervention: Drug: perflutren lipid microspheres
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00584402
200715241
No
John McGahan, MD, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: John P. McGahan, M.D. UC Davis School of Medicine Dept. of Radiology
University of California, Davis
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP