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Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI. (TACE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539253
First Posted: October 4, 2007
Last Update Posted: September 26, 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.
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
Results First Submitted: October 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Hepatocellular Carcinoma
Intervention: Drug: gadobenate dimeglumine (MultiHance)

  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

January, 2008 to May, 2012

People with hepatocellular carcinoma who were candidates for TACE who were referred to Johns Hopkins Hospital.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none observed

Reporting Groups
  Description
Gadabenate Dimeglumine( Multihance)

If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study

gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MRI imaging for both the baseline and 1 month f/u studies.


Participant Flow:   Overall Study
    Gadabenate Dimeglumine( Multihance)
STARTED   45 
COMPLETED   19 
NOT COMPLETED   26 



  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.
No text entered.

Reporting Groups
  Description
Gadobenate Dimeglumine (Multi Hance)

If patient did not participate in this study (by signing consent), they could receive any other contrast used routinely at this facility including the contrast used in this study

gadobenate dimeglumine (MultiHance): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.


Baseline Measures
   Gadobenate Dimeglumine (Multi Hance) 
Overall Participants Analyzed 
[Units: Participants]
 45 
Age 
[Units: Years]
Mean (Full Range)
 60.9 
 (43 to 73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      12  26.7% 
Male      33  73.3% 
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
 
United States   45 
[1] Percentage of enhancement changes observed using Triple-phase MultiHance-enhanced MRI


  Outcome Measures
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1.  Primary:   Nodule Size   [ Time Frame: 3 months ]

2.  Primary:   Nodule Enhancement   [ Time Frame: 3 month ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Ihab R. Kamel, M.D. PhD
Organization: Johns Hopkins Hospital
phone: 410-955-4567
e-mail: ikamel@jhmi.edu



Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00539253     History of Changes
Other Study ID Numbers: J06108
NA_00003943 ( Other Identifier: Johns Hopkins I.R.B. )
First Submitted: October 2, 2007
First Posted: October 4, 2007
Results First Submitted: October 12, 2016
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017