Safety and Efficacy of MultiHance in Pediatric Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Central Nervous System Diseases
• Intervention / Treatment: Drug: gadobenate dimeglumine

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Bracco Diagnostics, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gadobenate Dimeglumine	Drug: gadobenate dimeglumine; 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.; Other Names: MultiHance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre-dose and immediately 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	pre-dose and immediately 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	pre-dose and immediately 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	pre-dose to immediately post dose
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	pre-dose to immediately post dose
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	pre-dose to immediately 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	pre-dose and immediately 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	pre-dose to immediately 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	pre-dose to immediately postdose
The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events		up to 72 hours post dose

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Investigators: Study Director: Gianpaolo Pirovano, M.D., Bracco Diagnostics, Inc

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: May 5, 2006
• First Submitted That Met QC Criteria: May 5, 2006
• First Posted (Estimate): May 9, 2006

Study Record Updates

• Last Update Posted (Estimate): October 22, 2010
• Last Update Submitted That Met QC Criteria: October 13, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: disease of the central nervous system (brain or spine)
• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: MH 110