Safety and Efficacy of MultiHance in Pediatric Patients

Phase 3

Terminated

• Conditions: Central Nervous System Diseases
• Interventions: Drug: gadobenate dimeglumine

• Registration Number: NCT00323310
• Lead Sponsor: Bracco Diagnostics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2010-08-16
• Results First Submitted QC: 2010-09-20
• Status Verified: 2010-10
• Results First Posted: 2010-10-06
• Last Update Submitted: 2010-10-13
• Last Update Posted: 2010-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 92

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gadobenate Dimeglumine	gadobenate dimeglumine	-

Primary Outcome Measures

Name	Time	Method
Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1	pre-dose and immediately postdose	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	pre-dose and immediately postdose	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	pre-dose and immediately postdose	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	pre-dose to immediately post dose	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	pre-dose to immediately post dose	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	pre-dose to immediately postdose	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	pre-dose and immediately postdose	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	pre-dose to immediately postdose	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	pre-dose to immediately postdose	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	up to 72 hours post dose

Trial Locations

Locations (1)

Bracco Diagnostics, Inc.; 🇺🇸 Princeton, New Jersey, United States