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Study Comparing Gadoquatrane with Gadoteric Acid, Gadobutrol, and Gadoteridol for MRI in Adults with Brain or Spinal Cord Issues

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on evaluating the effectiveness and safety of a new contrast agent called gadoquatrane for use in MRI scans. The study is specifically looking at adults who have known or suspected issues with their brain or spinal cord, which are part of the central nervous system. The trial will compare gadoquatrane to other approved contrast agents that are already used in medical practice, such as gadoteric acid, gadobutrol, and gadoteridol. These agents help improve the clarity of MRI images, making it easier for doctors to see and diagnose problems.

The purpose of the study is to determine if gadoquatrane is as effective as the existing contrast agents. Participants in the study will undergo two MRI scans: one using gadoquatrane and another using one of the other approved contrast agents. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which contrast agent is being used during each scan. This helps ensure that the results are unbiased and reliable.

Throughout the study, researchers will assess various aspects of the MRI images, such as how well the contrast agent highlights different areas and how clearly it defines the structures within the brain or spinal cord. The study will also monitor any side effects or adverse reactions to the contrast agents. The goal is to provide valuable information about the potential benefits and risks of using gadoquatrane in MRI scans for diagnosing central nervous system conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be 18 years or older and require a contrast-enhanced MRI for known or suspected central nervous system issues.

    Participants must be able to undergo study procedures, including two MRI scans with contrast agents.

  2. Step 2

    First MRI scan

    The first MRI scan is performed using a contrast agent called gadoquatrane. This is administered intravenously at a dose of 0.04 mmol per kilogram of body weight.

    The scan aims to enhance the visibility of the central nervous system structures.

  3. Step 3

    Second MRI scan

    A second MRI scan is conducted using a different contrast agent, which is one of the approved macrocyclic gadolinium-based contrast agents (GBCAs) such as gadoteric acid, gadobutrol, or gadoteridol. This is also administered intravenously at a dose of 0.1 mmol per kilogram of body weight.

    This scan serves as a comparison to evaluate the effectiveness and safety of gadoquatrane.

  4. Step 4

    Evaluation of MRI results

    The MRI results are evaluated by a blinded independent central review (BICR) to assess visualization parameters such as enhancement, delineation, and morphology.

    The evaluation includes both pre- and post-contrast images from both MRI scans.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for any adverse events following the administration of the contrast agents. This monitoring period lasts for 24 hours after each MRI scan.

    The study aims to compare the number and intensity of any adverse events between the two contrast agents.

Who can join the trial?

4 criteria

  • Participant must be at least 18 years old at the time of signing the informed consent form.
  • Participants should have a medical reason for needing a **contrast-enhanced MRI**. This is a special type of scan that uses a dye to help see the brain and spinal cord more clearly. The dye used should be one of the approved types that are safe and effective, like gadobutrol, gadoterate meglumine/gadoteric acid, or gadoteridol.
  • Participants must be able to have the study-related procedures, which include having two **contrast-enhanced MRI** scans. One scan will use a new dye called gadoquatrane, and the other will use one of the approved dyes mentioned above. This will be decided by the participant and the study doctor.
  • Female participants must follow local rules about using birth control during the study. A female can join if she is not pregnant or breastfeeding and meets one of these conditions: she cannot have children, or she can have children but is using an acceptable birth control method during the study and for at least 24 hours after the last dose of the study treatment.

Who cannot join the trial?

7 criteria

  • Patients who are allergic to **contrast agents**. These are special dyes used in imaging tests to help doctors see inside the body more clearly.
  • Patients with severe **kidney problems**. The kidneys are organs that help filter waste from the blood.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients with a history of severe **allergic reactions**. An allergic reaction is when the body reacts strongly to something it doesn't like, such as certain foods or medicines.
  • Patients who have had a recent **heart attack**. A heart attack happens when blood flow to the heart is blocked.
  • Patients with **unstable medical conditions**. This means their health condition is not well-controlled or is changing rapidly.
  • Patients who are participating in another clinical trial. This is to avoid any interference with the results of the study.
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Investigated drugs

  • Gadoquatrane

    is a new contrast agent being tested for use in MRI scans. It is designed to help doctors see the central nervous system more clearly in patients who may have certain brain or spinal conditions. The trial is testing whether this new agent works as well as other similar agents already approved for use.

  • Macrocyclic Gadolinium-Based Contrast Agents (GBCAs)

    are existing contrast agents used in MRI scans to enhance the visibility of internal structures. These agents are already approved and commonly used to help diagnose conditions affecting the brain and spine by making the images clearer. The trial is comparing the effectiveness and safety of these agents with the new agent, gadoquatrane.

What is already known about the treatment

Gadoquatrane – Gadoquatrane is administered intravenously as a contrast agent for magnetic resonance imaging (MRI) to enhance the visibility of central nervous system pathologies. It is currently being evaluated in a Phase 3 clinical trial to determine its efficacy and safety compared to existing macrocyclic gadolinium-based contrast agents (GBCAs). The main therapeutic indication for gadoquatrane is to improve the contrast in MRI scans, aiding in the assessment of CNS conditions. At the molecular level, gadoquatrane works by altering the magnetic properties of nearby water molecules, enhancing the contrast of images. It is classified pharmacologically as a gadolinium-based contrast agent.

Investigated diseases

Central Nervous System Pathology – This term refers to a range of disorders affecting the brain and spinal cord. These conditions can include tumors, inflammation, infections, and degenerative diseases. They often lead to symptoms such as headaches, seizures, cognitive changes, or motor dysfunction, depending on the specific area of the central nervous system involved. The progression of these conditions varies widely; some may develop slowly over time, while others can progress rapidly. Imaging techniques like MRI are crucial for assessing these pathologies, helping to visualize abnormalities and guide further medical evaluation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501884-41-00Protocol code21181Estimated enrolment512 patientsSponsorBayer AG

sourced from the EU Clinical Trials Register and site verification

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