Safety and Efficacy of MultiHance in Pediatric Patients

Brief Summary

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”

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 Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
  • Study Primary Completion Date: September 2008

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Gadobenate Dimeglumine

Outcome Measures for this Clinical Trial

Primary Measures

  • Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 1
    • Time Frame: pre-dose and immediately postdose
      Safety Issue?: No
  • Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 2
    • Time Frame: pre-dose and immediately postdose
      Safety Issue?: No
  • Delineation of Lesion Border (Change From Pre to Pre+Postdose) for Reader 3
    • Time Frame: pre-dose and immediately postdose
      Safety Issue?: No
  • Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 1
    • Time Frame: pre-dose to immediately post dose
      Safety Issue?: No
  • Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 2
    • Time Frame: pre-dose to immediately post dose
      Safety Issue?: No
  • Visualization of Lesion Internal Morphology (Change From Pre to Pre+Postdose) for Reader 3
    • Time Frame: pre-dose to immediately postdose
      Safety Issue?: No
  • Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 1
    • Time Frame: pre-dose and immediately postdose
      Safety Issue?: No
  • Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 2
    • Time Frame: pre-dose to immediately postdose
      Safety Issue?: No
  • Lesion Contrast Enhancement (CE) (Change From Pre to Pre+Postdose) for Reader 3
    • Time Frame: pre-dose to immediately postdose
      Safety Issue?: No
  • The Number of Patients Administered MultiHance (Gadobenate Dimeglumine) Reporting Adverse Events
    • Time Frame: up to 72 hours post dose
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Bracco Diagnostics, Inc
  • Provider of Information About this Clinical Study
    • Gianpaolo Pirovano, Executive Director, Corporate Medical Development, Bracco Diagnostics, Inc
  • Overall Official(s)
    • Gianpaolo Pirovano, M.D., Study Director, Bracco Diagnostics, Inc

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00323310