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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):
University of California, Davis

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Liver Neoplasms
Intervention Drug: perflutren lipid microspheres
Enrollment 8
Recruitment Details Closed to enrollment
Pre-assignment Details Closed to enrollment
Arm/Group Title Contrast Sonography
Hide Arm/Group Description

Contrast-enhanced sonography

perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Contrast Sonography
Hide Arm/Group Description Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Male
5
  62.5%
Female
3
  37.5%
1.Primary Outcome
Title Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
Hide Description 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.
Time Frame 15 min
Hide Outcome Measure Data
Hide Analysis Population Description
Tumors were evaluated prior and post contrast injection, 1 tumor per participant
Arm/Group Title Contrast Sonography
Hide Arm/Group Description:
Subjects undergoing contrast sonography
Overall Number of Participants Analyzed 8
Overall Number of Units Analyzed
Type of Units Analyzed: Tumor
8
Count of Units
Unit of Measure: tumor
8
 100.0%
2.Secondary Outcome
Title 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
Hide Description 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
Time Frame 15 min
Hide Outcome Measure Data
Hide Analysis Population Description
Tumor types showed differences in enhancement
Arm/Group Title Contrast Sonography
Hide Arm/Group Description:
Subjects undergoing contrast sonography
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
8
Time Frame 15 min post injection
Adverse Event Reporting Description All-cause mortality and other (not including serious) adverse events were not collected/assessed
 
Arm/Group Title Contrast Sonography
Hide Arm/Group Description

Contrast-enhanced sonography

perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity

All-Cause Mortality
Contrast Sonography
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Contrast Sonography
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Contrast Sonography
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John McGahan, M.D.
Organization: University of Califonia, Davis
Phone: (916)734-0519
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00584402     History of Changes
Other Study ID Numbers: 200715241
First Submitted: December 21, 2007
First Posted: January 2, 2008
Results First Submitted: July 3, 2013
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017