Safety and Efficacy of MultiHance in Pediatric Patients

This study has been terminated.
(Adequate statistical power at 92 dosed pts to meet study objectives.)
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00323310
First received: May 5, 2006
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Central Nervous System Diseases
Drug: gadobenate dimeglumine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1 [ Time Frame: pre-dose and immediately postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-dose and immediately postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-dose and immediately postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-dose to immediately post dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-dose to immediately post dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-dose to immediately postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-dose and immediately postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-dose to immediately postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: pre-dose to immediately postdose ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 72 hours post dose ] [ Designated as safety issue: Yes ]

Enrollment: 92
Study Start Date: April 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MultiHance

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323310

Locations
United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Director: Gianpaolo Pirovano, M.D. Bracco Diagnostics, Inc
  More Information

No publications provided

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
Study First Received: May 5, 2006
Results First Received: August 16, 2010
Last Updated: October 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bracco Diagnostics, Inc:
disease of the central nervous system (brain or spine)

Additional relevant MeSH terms:
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014