Skip to main content
OpenTrials
Completed

NCT Number: NCT04307186

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Nervous System Pathology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UMHAT Sveti Georgi, Plovdiv, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gadoquatrane (BAY1747846)

Drug

Solution for IV injection, single dose

Gadobutrol (Gadovist/Gadavist)

Drug

Solution for IV injection, single dose

Primary outcomes

  1. Overall Diagnostic Preference

    Time frame: At 5 minute post each injection

    Overall diagnostic preference using a matched pairs approach was evaluated by 3 blinded readers using an ordinal 5-point scale (greatly prefer gadoquatrane, prefer gadoquatrane, no preference, prefer gadobutrol, greatly prefer gadobutrol). Percentage of participants and the respective Wald confidence intervals (CI) for image preference were reported for each of the 3 readers based on the 3-point preference scale (1=greatly prefer/prefer gadoquatrane, 0=no preference, -1=greatly prefer/prefer gadobutrol). If 2 or 3 readers reach the same conclusion on the recommended action (e.g. no dose adjustment needed), then this will be the recommended action taken.

Secondary outcomes

  1. Sum of Lesion Visualization Parameters on Post-contrast Images

    Time frame: At 5 minute post each injection

    The 3 lesion visualization parameters (border delineation/degree of contrast enhancement/internal morphology) were combined by adding them up for each participant and each blinded reader, leading to only one variable on an ordinal 11-point scale (the higher values represent a better lesion visualization). Average reader was the mean of the 3 blinded readers averages of the scores per participant. Lesion border delineation: measured on a 4-point scale (1=None [no/unclear delineation of the lesion boundaries] to 4=Excellent [clear and complete delineation]). Degree of lesion contrast enhancement: measured on a 4-point scale (1=No [lesion is not enhanced] to 4=Excellent [lesion is clearly and brightly enhanced]). Lesion internal morphology: measured on a 3-point scale (1=Poor [structure and internal morphology of the lesion is poorly visible] to 3=Good [structure and internal morphology of the lesion is sufficiently visible]).

  2. Lesion Visualization Parameter Border Delineation on Pre-contrast and Combined Pre- and Post-contrast Images

    Time frame: At pre-injection and 5 minute post each injection

    Lesion border delineation: up to 5 of the largest lesions were selected and scored using a 4-point scale (1=None [no/unclear delineation of the lesion boundaries] to 4=Excellent [clear and complete delineation]; the higher values represent a better lesion border delineation). Average reader was the mean of the 3 blinded readers averages of the scores per participant.

  3. Lesion Visualization Parameter Contrast Enhancement on Pre-contrast and Combined Pre- and Post-contrast Images

    Time frame: At pre-injection and 5 minute post each injection

    Degree of lesion contrast enhancement: up to the 5 largest lesions were selected and scored using a 4-point scale (1=No [lesion is not enhanced] to 4=Excellent [lesion is clearly and brightly enhanced]; the higher values represent a better degree of lesion contrast enhancement). Average reader was the mean of the 3 blinded readers averages of the scores per participant.

  4. Lesion Visualization Parameter Internal Morphology on Pre-contrast and Combined Pre- and Post-contrast Images

    Time frame: At pre-injection and 5 minute post each injection

    Lesion internal morphology: up to 5 of the largest lesions were selected and scored using a 3-point scale (1=Poor [structure and internal morphology of the lesion is poorly visible] to 3=Good [structure and internal morphology of the lesion is sufficiently visible]; the higher values represent a better lesion internal morphology). Average reader was the mean of the 3 blinded readers averages of the scores per participant.

  5. Number of Lesions on Pre-contrast and Combined Pre- and Post-contrast Images

    Time frame: At pre-injection and 5 minute post injection

    The 3 blinded readers recorded the total number of lesions for each pre-contrast and combined pre- and post-contrast magnetic resonance image set separately. The numbers of participants by number of detected lesions were reported.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2020
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.