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A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

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Trial Profile

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 May 2025

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At a glance

  • Drugs Gadobutrol (Primary) ; Gadoquatrane (Primary) ; Gadoterate-meglumine (Primary) ; Gadoteridol (Primary)
  • Indications Brain disorders; Spinal cord disorders
  • Focus Diagnostic use; Registrational
  • Acronyms Quanti OBR
  • Sponsors Bayer

Most Recent Events

  • 10 Jan 2025 According to Bayer Media Release, Bayer plans to submit a comprehensive data package which will include the QUANTI study results to health authorities worldwide to secure marketing authorization.
  • 10 Jan 2025 According to Bayer Media Release, Primary endpoint (Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR) has been met.
  • 10 Jan 2025 According to Bayer Media Release, Primary endpoint (Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR) has been met.

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