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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Gadobenic acid
Gadolinium DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014