Back to resultsSafety and Efficacy of MultiHance in Pediatric Patients
Primary Purpose
Central Nervous System Diseases
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
gadobenate dimeglumine
Sponsored by
About this trial
This is an interventional diagnostic trial for Central Nervous System Diseases focused on measuring disease of the central nervous system (brain or spine)
Eligibility Criteria
Inclusion Criteria: Between 2 and 17 years of age Informed consent from parents Assent from patient where required Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination Exclusion Criteria: Contraindication to MRI Undergoing MRI in an emergency situation Known allergy to one or more of the ingredients in MultiHance Sickle cell anemia moderate to severe renal impairment Received another investigational compound within 30 days Pregnancy Lactating females Likely to undergo an invasive procedure within 72 hours of receiving MultiHance
Sites / Locations
- Bracco Diagnostics, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gadobenate Dimeglumine
Arm Description
Outcomes
Primary Outcome Measures
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
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
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
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
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
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
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
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
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
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
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
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
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
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
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
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
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
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
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00323310
Brief Title
Safety and Efficacy of MultiHance in Pediatric Patients
Official Title
A Phase III Multi-Center Open Label Study to Evaluate Safety and Efficacy of MultiHance at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Why Stopped
Adequate statistical power at 92 dosed pts to meet study objectives.
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bracco Diagnostics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Diseases
Keywords
disease of the central nervous system (brain or spine)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gadobenate Dimeglumine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gadobenate dimeglumine
Other Intervention Name(s)
MultiHance
Intervention Description
A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.
Primary Outcome Measure Information:
Title
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
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
Title
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
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
Title
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
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
Title
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
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
Title
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
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
Title
Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
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
Title
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
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
Title
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
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
Title
Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
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
Title
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
Time Frame
up to 72 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 2 and 17 years of age
Informed consent from parents
Assent from patient where required
Known or highly suspected disease of the CNS and referred for either cranial or spinal MRI examination
Exclusion Criteria:
Contraindication to MRI
Undergoing MRI in an emergency situation
Known allergy to one or more of the ingredients in MultiHance
Sickle cell anemia moderate to severe renal impairment
Received another investigational compound within 30 days
Pregnancy
Lactating females
Likely to undergo an invasive procedure within 72 hours of receiving MultiHance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianpaolo Pirovano, M.D.
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Bracco Diagnostics, Inc.
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of MultiHance in Pediatric Patients
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