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

Bayer

Status and phase: Completed; Phase 2

Conditions: Central Nervous System Pathology

Treatments: Drug: Gadobutrol (Gadovist/Gadavist); Drug: Gadoquatrane (BAY1747846)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04307186

2019-001560-30 (EudraCT Number)

20241

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Gadobutrol + Gadoquatrane

Experimental group

Description:

Participants will receive one intravenous (IV) injection of gadobutrol 0.1 millimole(s) gadolinium/kilogram body weight (mmol Gd/kg bw) and one IV injection of Gadoquatrane (BAY1747846).

Treatment:

Drug: Gadobutrol (Gadovist/Gadavist)

Drug: Gadoquatrane (BAY1747846)