- AuthorisedTherapeutic use (Phase IV)
Prospective evaluation of potential effects of repeated gadolinium-based contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in comparison to a non-GBCA exposed control group—ODYSSEY
This study, called ODYSSEY, checks if repeated use of certain MRI dyes over five years affects your movement or thinking. It compares people who get these dyes to those who don't. We want to understand if there are any long-term effects.
Italy · Germany · France - 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)
(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