Safety and Efficacy of MultiHance in Pediatric Patients

NCT00323310 | Terminated Phase 3 Results

• 1 other identifier: MH 110
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Diseases

Keywords

disease of the central nervous system (brain or spine)

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Gadobenate Dimeglumine

EXPERIMENTAL

Drug: gadobenate dimeglumine

Interventions

gadobenate dimeglumine DRUG

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.

Also known as: MultiHance

Gadobenate Dimeglumine

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Bracco Diagnostics, Inc.

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Central Nervous System Diseases

Interventions

gadobenic acid

Condition Hierarchy (Ancestors)

Nervous System Diseases

Results Point of Contact

• Title: Usha Halemane/Executive Director
• Organization: Bracco Diagnostics Inc

usha.halemane@diag.bracco.com

609-514-2578

Study Officials

• Gianpaolo Pirovano, M.D.

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 9, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 22, 2010
• Results First Posted: October 6, 2010

Record last verified: 2010-10

Locations

US (1)