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A Multicenter, Prospective, Open-label Study to Evaluate the Pharmacokinetics and Safety of Gadoquatrane in Pediatric Participants (From Birth to <18 Years) Undergoing Contrast-enhanced Magnetic Resonance Imaging (CE-MRI)

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Trial Profile

A Multicenter, Prospective, Open-label Study to Evaluate the Pharmacokinetics and Safety of Gadoquatrane in Pediatric Participants (From Birth to <18 Years) Undergoing Contrast-enhanced Magnetic Resonance Imaging (CE-MRI)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2025

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At a glance

  • Drugs Gadoquatrane (Primary)
  • Indications CNS disorders
  • Focus Pharmacokinetics; Registrational
  • Acronyms Quanti Pediatric
  • Sponsors Bayer

Most Recent Events

  • 17 Jun 2025 According to a Bayer Media Release,announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients including term neonates. The submission of gadoquatrane to the US FDA is based on positive data from the pivotal Phase III QUANTI studies.
  • 02 Jun 2025 According to a Bayer Media Release, company announced the submission of a marketing authorization application to the Ministry of Health, Labour, and Welfare in Japan for its investigational contrast agent gadoquatrane for contrast enhancement in MRI to detect and visualize known or suspected pathologies in all body regions and the central nervous system (CNS) in adults and pediatric patients including neonates. The submission is based on positive data from the pivotal Phase III QUANTI studies.
  • 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.

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