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Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

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Trial Profile

Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2023

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At a glance

  • Drugs Gadopiclenol (Primary) ; Gadobutrol
  • Indications Advanced breast cancer; CNS disorders; Head and neck cancer; Liver cancer; Ovarian cancer; Pancreatic cancer; Prostate cancer; Renal cancer; Uterine cancer
  • Focus Diagnostic use; Registrational
  • Acronyms PROMISE
  • Sponsors Guerbet

    • Most Recent Events

    • 11 Dec 2023 According to a Guerbet media release, Primary endpoint (Lesion visualization criteria for gadopiclenol-enhanced MRI compared to gadobutrol-enhanced MRI)has been met.
    • 11 Dec 2023 According to a Guerbet media release, Primary endpoint (Lesion visualization criteria for gadopiclenol-enhanced MRI compared to unhenhanced MRI) has been met.
    • 11 Dec 2023 According to a Guerbet media release, the marketing authorisation (MA) for Elucirem (Gadopiclenol) was granted for use in contrast-enhanced magnetic resonance imaging (MRI) to Guerbet by the European Commission based on the positive opinion of the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP).

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