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Trial record 3 of 95 for:    gadobenate dimeglumine

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

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ClinicalTrials.gov Identifier: NCT00539253
Recruitment Status : Completed
First Posted : October 4, 2007
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Sponsor:
Collaborator:
Bracco Diagnostics, Inc
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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)
Enrollment 45
Recruitment Details

January, 2008 to May, 2012

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

Pre-assignment Details none observed
Arm/Group Title Gadabenate Dimeglumine( Multihance)
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 45
Completed 19
Not Completed 26
Arm/Group Title Gadobenate Dimeglumine (Multi Hance)
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
60.9
(43 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
12
  26.7%
Male
33
  73.3%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 45 participants
45
 100.0%
[1]
Measure Description: Percentage of enhancement changes observed using Triple-phase MultiHance-enhanced MRI
1.Primary Outcome
Title Nodule Size
Hide Description Maximal nodule size measured in centimeters
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed reflects the number of participants for whom data was available.
Arm/Group Title Multihance
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: centimeters
6.4  (4.5)
2.Primary Outcome
Title Nodule Enhancement
Hide Description Percent area of nodule with enhancement
Time Frame 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed reflects the number of participants for whom data was available
Arm/Group Title Multihance
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: percent enhancement
32.8  (30.7)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadobenate Dimeglumine (Multi Hance)
Hide Arm/Group Description

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.

All-Cause Mortality
Gadobenate Dimeglumine (Multi Hance)
Affected / at Risk (%)
Total   0/45 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Gadobenate Dimeglumine (Multi Hance)
Affected / at Risk (%)
Total   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gadobenate Dimeglumine (Multi Hance)
Affected / at Risk (%)
Total   0/45 (0.00%) 
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
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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