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
Condition: Central Nervous System Pathology
Intervention: Gadoquatrane (BAY1747846); Gadobutrol (Gadovist/Gadavist)
Intervention description: Solution for IV injection, single dose; Solution for IV injection, single dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: This is a one-way crossover study with blinded participants and blinded image readers
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CNS

Summary:

      Researchers in this study want to find the appropriate dose of drug BAY1747846 for adults
      undergoing MRI for known or highly suspected brain and/or spinal cord conditions so that the
      image quality is similar to that of drug gadobutrol for adults undergoing MRI. MRI stands for
      Magnetic resonance imaging which produces body pictures created by using magnetic energy
      rather than x-ray energy.

      Both BAY1747846 and gadobutrol are medicinal products known as gadolinium-based contrast
      agents (GBCA) which are used in MRI examinations to provide contrast enhancement and improve
      imaging performance. Gadobutrol (brand name: Gadavist, Gadovist) has been approved worldwide
      for the diagnosis of various disorders in adult and pediatric patients. BAY1747846 is a new
      GBCA under development with the goal to provide similar imaging performances in MRI.
      Participants in this study will receive both BAY1747846 and gadobutrol with a period of 3 -
      14 days in between. A MRI examination will be performed after each injection. Participant
      will stay in this study for 2 - 4 weeks depending on the scheduling of the visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be at least 18 years of age at the time of signing the informed
             consent.

          -  Known or highly suspected CNS pathology (contrast-enhancing CNS lesion) referred for
             contrast-enhanced MRI of the CNS.

          -  Male and female.

          -  Estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m^2.

        Exclusion Criteria:

          -  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:

               -  Lepto-meningeal disease (e.g. leptomeningeal carcinomatosis). Dural lesions (e.g.
                  meningiomas) fulfilling inclusion criteria #2 are not excluded

               -  Pituitary adenomas (macro and micro)

               -  Tumors of the choroid plexus

               -  Tumors of the pineal gland

               -  Dermoid/epidermoid tumors

               -  Infectious disease (e.g. brain abscess, cisticercosis, etc.)

               -  Venous angiomas

               -  Subacute/chronic ischemia

               -  Encephalitis

               -  Multiple sclerosis (acute and chronic)

               -  Optic neuritis

               -  Chordomas

               -  Von Hippel Lindau syndrome

               -  Hypertensive leukoencephalopathy.

          -  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.