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Trial record 2 of 95 for:    gadobenate dimeglumine

Safety and Efficacy of MultiHance in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT00323310
Recruitment Status : Terminated (Adequate statistical power at 92 dosed pts to meet study objectives.)
First Posted : May 9, 2006
Results First Posted : October 6, 2010
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:
Bracco Diagnostics, Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Central Nervous System Diseases
Intervention Drug: gadobenate dimeglumine
Enrollment 92
Recruitment Details Patients were recruited from April 2006 to July 2008 at 17 investigational sites. The blinded read was conducted from September 12, 2008 to September 26, 2008.
Pre-assignment Details 94 patients enrolled; 92 patients dosed.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description Contrast Agent, 0.10 mmol/kg injection
Period Title: Overall Study
Started 92
Completed 89
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
a parent refused blood draw             1
did not complete the 24-hr f-up visit             1
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description Contrast Agent, 0.10 mmol/kg injection
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
<=18 years
92
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants
10.59  (4.017)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
47
  51.1%
Male
45
  48.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 92 participants
United States 35
Europe 47
Canada 1
China 9
1.Primary Outcome
Title Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
Hide Description 5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Time Frame pre-dose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
148
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 1.7  (1.16)
Pre+Postdose 3.0  (1.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.1 to 1.5
Parameter Dispersion
Type: Standard Deviation
Value: 1.46
Estimation Comments [Not Specified]
2.Primary Outcome
Title Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
Hide Description 5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Time Frame pre-dose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
135
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 1.9  (1.15)
Pre+Postdose 3.1  (1.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.9 to 1.4
Parameter Dispersion
Type: Standard Deviation
Value: 1.45
Estimation Comments [Not Specified]
3.Primary Outcome
Title Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
Hide Description 5-point scale (0=no delineation of lesion borders [lesion not identified in image, lesion borders not visible]; 1=poor border delineation [all borders poorly distinct, lesion not separated from surrounding tissues/structures/edema]; 2=moderate border delineation [border delineation fair/not complete, lesion not clearly separated]; 3=good border delineation [border delineation complete, lesion adequately separated]; 4=excellent border delineation [borders sharply/clearly distinct, lesion sharply separated]) paired assessment to compare the difference between pre to pre+postdose
Time Frame pre-dose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
131
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 1.7  (1.19)
Pre+Postdose 2.4  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.4 to 0.9
Parameter Dispersion
Type: Standard Deviation
Value: 1.42
Estimation Comments [Not Specified]
4.Primary Outcome
Title Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
Hide Description 5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Time Frame pre-dose to immediately post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
148
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 1.9  (1.18)
Pre+Postdose 3.2  (1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.1 to 1.6
Parameter Dispersion
Type: Standard Deviation
Value: 1.56
Estimation Comments [Not Specified]
5.Primary Outcome
Title Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
Hide Description 5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Time Frame pre-dose to immediately post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
135
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 2.1  (1.17)
Pre+Postdose 3.2  (1.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.8 to 1.4
Parameter Dispersion
Type: Standard Deviation
Value: 1.49
Estimation Comments [Not Specified]
6.Primary Outcome
Title Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
Hide Description 5-point scale (0=no visualization of lesion internal morphology (LIM) [lesion not identified in image, not visible]; 1=poor visualization of LIM [insufficiently depicted, intralesional features poorly identified]; 2=moderate visualization of LIM [not completely depicted, some intralesional features visible]; 3=good visualization of LIM [completely depicted, intralesional features adequately identified]; 4=excellent visualization of LIM [optimally depicted, intralesional features clearly identified and characterized]) paired assessment to compare the difference between pre to pre+postdose
Time Frame pre-dose to immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
131
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 1.4  (1.06)
Pre+Postdose 2.0  (1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.4 to 0.8
Parameter Dispersion
Type: Standard Deviation
Value: 1.20
Estimation Comments [Not Specified]
7.Primary Outcome
Title Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
Hide Description 5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Time Frame pre-dose and immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
148
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 1.8  (1.16)
Pre+Postdose 3.0  (1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
1.0 to 1.5
Parameter Dispersion
Type: Standard Deviation
Value: 1.57
Estimation Comments [Not Specified]
8.Primary Outcome
Title Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
Hide Description 5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Time Frame pre-dose to immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
135
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 2.0  (1.20)
Pre+Postdose 3.2  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
0.9 to 1.4
Parameter Dispersion
Type: Standard Deviation
Value: 1.49
Estimation Comments [Not Specified]
9.Primary Outcome
Title Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
Hide Description 5-point scale (0=no lesion CE [lesion not identified in image, no contrast between lesion and surrounding normal brain/spine tissue]; 1=poor lesion CE [diff. in signal intensity (SI) poor, lesion barely identified, not possible to evaluate/measure size]; 2=moderate lesion CE [diff. in SI fair, lesion identified, not possible to evaluate/measure size]; 3=good lesion CE [diff. in SI adequate, lesion identified, size evaluated/measured]; 4=excellent lesion CE [diff. in SI marked, lesion identified, size measured]) paired assessment to compare the diff. between pre to pre+postdose
Time Frame pre-dose to immediately postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Include all ITT population. The number of units analyzed are the total number of lesions assessed by the reader from the total number of participants.
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
131
Mean (Standard Deviation)
Unit of Measure: Units on a Scale (0 to 4)
Predose 1.4  (0.96)
Pre+Postdose 2.2  (1.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadobenate Dimeglumine
Comments Paired t-test to compare change from pre to pre+postdose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments H0: udiff = 0; Ha: udiff not = 0
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.6 to 1.1
Parameter Dispersion
Type: Standard Deviation
Value: 1.54
Estimation Comments [Not Specified]
10.Primary Outcome
Title The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
Hide Description [Not Specified]
Time Frame up to 72 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Included all dosed patients (safety population).
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description:
Contrast Agent, 0.10 mmol/kg injection
Overall Number of Participants Analyzed 92
Measure Type: Number
Unit of Measure: Participants
8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadobenate Dimeglumine
Hide Arm/Group Description Contrast Agent, 0.10 mmol/kg injection
All-Cause Mortality
Gadobenate Dimeglumine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gadobenate Dimeglumine
Affected / at Risk (%) # Events
Total   0/92 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Gadobenate Dimeglumine
Affected / at Risk (%) # Events
Total   8/92 (8.70%)    
Eye disorders   
Eyelid oedema  3  1/92 (1.09%)  1
Gastrointestinal disorders   
Abdominal discomfort  1  1/92 (1.09%)  1
Constipation  2  1/92 (1.09%)  1
Vomiting  3  1/92 (1.09%)  1
Infections and infestations   
Otitis media  3  1/92 (1.09%)  1
Nervous system disorders   
Headache  3  2/92 (2.17%)  2
Somnolence  3  1/92 (1.09%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  3  1/92 (1.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA (10.1)
3
Term from vocabulary, MedDRA (10.0)
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.
The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.
Results Point of Contact
Name/Title: Usha Halemane/Executive Director
Organization: Bracco Diagnostics Inc
Phone: 609-514-2578
Responsible Party: Gianpaolo Pirovano, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00323310     History of Changes
Other Study ID Numbers: MH 110
First Submitted: May 5, 2006
First Posted: May 9, 2006
Results First Submitted: August 16, 2010
Results First Posted: October 6, 2010
Last Update Posted: October 22, 2010