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An Open Label, Multi-center, Phase 3 Study With Corresponding Blinded Image Reading to Determine the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Gadobutrol 1.0 Molar (Gadovist) in Patients With Newly Diagnosed Breast Cancer Referred for Contrast-enhanced Breast MRI

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Trial Profile

An Open Label, Multi-center, Phase 3 Study With Corresponding Blinded Image Reading to Determine the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Gadobutrol 1.0 Molar (Gadovist) in Patients With Newly Diagnosed Breast Cancer Referred for Contrast-enhanced Breast MRI

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Dec 2014

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At a glance

  • Drugs Gadobutrol (Primary)
  • Indications Breast cancer
  • Focus Diagnostic use; Registrational
  • Acronyms GEMMA 1
  • Sponsors Bayer

Most Recent Events

  • 25 Jun 2014 New trial record
  • 12 Jun 2014 Results of this and another trial (CT profile 246109) have been reported in a Bayer media release.
  • 12 Jun 2014 According to a Bayer media release, gadobutrol was approved to assess the presence and extent of malignant breast disease on the basis of the results from this and another trial (see CTI profile 246109).

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