A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems

Summary

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).

MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.

The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.

The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.

The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.

Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.

At the start or during the study, the doctors and their study team will:

* take blood and urine samples
* do physical examinations
* check blood pressure and heart rate
* review the MRI scans obtained in the study and decide on the diagnosis
* ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Conditions

• Contrast Enhancement in Magnetic Resonance Imaging
• Central Nervous System Pathology

Interventions

DRUG

Gadoquatrane (BAY1747846)

0.04 mmol Gd/kg body weight, solution for intravenous injection, single dose

DRUG

Gadobutrol

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

DRUG

Gadoterate meglumine

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

DRUG

Gadoteridol

Approved standard of care macrocyclic GBCA, 0.1 mmol Gd/kg body weight, solution for intravenous injection, single dose

Sponsors & Collaborators

• Bayer

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-24

Primary Completion

2024-05-30

Completion

2024-05-31

FDA Drug

Yes

Countries

• United States
• Argentina
• Bulgaria
• Canada
• China
• Czechia
• France
• Germany
• Hungary
• Italy
• Japan
• South Korea
• Sweden
• Turkey (Türkiye)
• United Kingdom

Study Locations