Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
Receipt of any contrast agent \< 72 h prior to the study MRIs, or planned receipt of any contrast agent within 72 h after the second study MRI.
Planned or expected biopsy in the region of interest or any interventional therapeutic procedure from the first study MRI up to 24 h after the second study MRI.
Planned or expected change in any treatment or procedure between the two study MRIs that may alter image comparability and /or chemotherapy which is changed between the two MRI procedures.
Contraindications to the administration of gadobutrol, as specified in the local product label.
You may not be if
Considered clinically unstable or has a concomitant/intercurrent condition (e.g. COVID-19 infection) that would not allow participation for the full planned study period (i.e. period 1, 2 or both) in the judgement of the investigator.
Severe cardiovascular disease.
Patients undergoing liver transplantation.
Any contraindication to MRI examinations.
History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents, foods, chemicals or other substances.
History of allergic asthma and/ or atopic dermatitis.
Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI:
Clareo Health | Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions
