Multicenter, Single-blind, Adaptive Dose Finding Study of Single Intravenous Injections of BAY 1747846 With Corresponding Blinded Read in Adult Participants With Known or Highly Suspected CNS Lesions Referred for Contrast-enhanced MRI of the CNS

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Updated on 16 September 2022


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.

Condition Central Nervous System Pathology
Treatment BAY1747846, Gadobutrol (Gadovist/Gadavist)
Clinical Study IdentifierNCT04307186
Last Modified on16 September 2022


Yes No Not Sure

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
Any contraindication to MRI examinations
Patients undergoing liver transplantation
History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents, foods, chemicals or other substances
Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI
History of allergic asthma and/ or atopic dermatitis
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
Multiple sclerosis (acute and chronic)
Optic neuritis
Von Hippel Lindau syndrome
Hypertensive leukoencephalopathy
Receipt of any contrast agent < 72 h prior to the study MRIs, or planned receipt of
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
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
any contrast agent within 72 h after the second study MRI
Contraindications to the administration of gadobutrol, as specified in the local product label
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