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

  • STATUS
    Recruiting
  • End date
    Apr 12, 2022
  • participants needed
    180
  • sponsor
    Bayer
Updated on 19 March 2021

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.

Details
Condition Central Nervous System Pathology
Treatment BAY1747846, Gadobutrol (Gadovist/Gadavist)
Clinical Study IdentifierNCT04307186
SponsorBayer
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Central Nervous System Pathology??
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
Severe cardiovascular disease
Any contraindication to MRI examinations
History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents
History of allergic asthma
Suspected lesions or suffering from any of the following CNS diseases/lesion types as the main indication for MRI
Meningeal disease (focal enhancement)
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 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 (depending on local product label)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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