- Ongoing, recruitingTherapeutic confirmatory (Phase III)
(21181) 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 the central nervous system (CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs)
This study is testing a new, lower-dose contrast dye called gadoquatrane for MRI brain scans. It wants to see if it's as good and safe as current higher-dose dyes at showing problems in the brain and spinal cord, like tumours or inflammation.
For: Contrast enhancement in magnetic resonance imaging for assessment of central nervous system pathologySweden · France · Bulgaria - Ongoing, recruitingTherapeutic confirmatory (Phase III)
(21197) 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)
This study compares a new MRI dye, gadoquatrane, with existing dyes. It aims to see if the new dye helps doctors get clearer images of body parts (but not the brain or spine) and if it's safe to use.
For: Contrast enhancement in magnetic resonance imaging for assessment of non-central nervous system pathologyCzechia · Sweden · Italy - Ongoing, recruitingTherapeutic confirmatory (Phase III)
(21196) 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)
This study looks at a new contrast dye called gadoquatrane in children having MRI scans. We want to see how the body handles the dye and if it's safe. This helps us understand if it's a good option for children of all ages needing these special scans.
For: Contrast enhancement in magnetic resonance imaging in childrenPoland · Sweden · Czechia