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Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584402
First Posted: January 2, 2008
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
December 21, 2007
January 2, 2008
July 3, 2013
July 11, 2017
July 11, 2017
April 2007
March 2009   (Final data collection date for primary outcome measure)
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.
estimation of the the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography [ Time Frame: 3 years ]
Complete list of historical versions of study NCT00584402 on ClinicalTrials.gov Archive Site
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
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 ]
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: None (Open Label)
Primary Purpose: Diagnostic
Liver Neoplasms
Drug: perflutren lipid microspheres
perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Other Name: Definity
Experimental: Contrast sonography
Contrast-enhanced sonography perflutren lipid microspheres
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00584402
200715241
No
Not Provided
Plan to Share IPD: No
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
July 2017

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