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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
Results First Submitted: July 3, 2013  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Closed to enrollment

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Closed to enrollment

Reporting Groups
  Description
Contrast Sonography

Contrast-enhanced sonography

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


Participant Flow:   Overall Study
    Contrast Sonography
STARTED   8 
COMPLETED   8 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Contrast Sonography Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity

Baseline Measures
   Contrast Sonography 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8 100.0% 
>=65 years      0   0.0% 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
 
Male   5 
Female   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography   [ Time Frame: 15 min ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: john.mcgahan@ucdmc.ucdavis.edu



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