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The 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 Who Are Less Than 2 Years of Age

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Trial Profile

The 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 Who Are Less Than 2 Years of Age

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 04 Feb 2018

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At a glance

  • Drugs Gadobenic acid (Primary)
  • Indications CNS disorders
  • Focus Diagnostic use
  • Sponsors Bracco Diagnostics

    • Most Recent Events

    • 30 Jan 2018 According to a Bracco Diagnostics media release, based on the results of this study, company received the US FDA approval for MultiHance for an extension to include MRI of the CNS in pediatric patients younger than 2 years of age (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues.
    • 18 Jul 2016 Status changed from recruiting to completed.
    • 19 May 2015 Status changed from not yet recruiting to recruiting, according to to ClinicalTrials.gov record.

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