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Study Comparing Gadoquatrane with Gadoteric Acid, Gadoteridol, and Gadobutrol for MRI in Patients with Non-CNS Conditions

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 effects and safety of a new contrast agent called gadoquatrane for use in MRI (Magnetic Resonance Imaging) tests. The study is designed for adults who have known or suspected health issues in any part of the body, except for the brain or spinal cord. The purpose of the study is to compare gadoquatrane with other already approved contrast agents, specifically gadoteric acid, gadoteridol, and gadobutrol, which are commonly used in MRI procedures.

Participants in the study will undergo two MRI scans. One scan will use the new contrast agent, gadoquatrane, and the other will use one of the approved contrast agents. The contrast agents are substances that help improve the clarity of the images produced by the MRI, making it easier for doctors to see and assess any abnormalities. The study aims to determine if gadoquatrane is as effective and safe as the other contrast agents currently in use.

The study will involve a series of MRI scans to assess the effectiveness of the contrast agents in enhancing the images. The results will help determine if gadoquatrane can be a reliable alternative to the existing contrast agents. Participants will be monitored for any side effects or adverse reactions during the study period, which will last for a short duration. The findings from this study could potentially lead to improved imaging options for patients undergoing MRI scans for various health conditions.

The research process

The trial runs in 6 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, you will be required to sign an informed consent form. This form confirms your understanding of the study and your agreement to participate.

    You must be at least 18 years old and have a medical reason for needing a contrast-enhanced MRI, excluding issues related to the brain or spinal cord.

  2. Step 2

    First MRI examination

    You will undergo the first MRI examination. During this procedure, a contrast agent will be administered through an intravenous injection. This agent helps to improve the clarity of the MRI images.

    The contrast agent used in this examination will be one of the approved macrocyclic gadolinium-based contrast agents (GBCAs), such as gadobutrol, gadoteric acid, or gadoteridol.

  3. Step 3

    Second MRI examination

    A second MRI examination will be conducted. This time, the contrast agent gadoquatrane will be used. It will also be administered through an intravenous injection.

    The purpose of using different contrast agents is to compare their effectiveness and safety in enhancing MRI images.

  4. Step 4

    Evaluation of MRI results

    The MRI images from both examinations will be evaluated by a team of experts. They will assess the quality of the images and the effectiveness of the contrast agents in highlighting any abnormalities.

    The evaluation will focus on several visualization parameters, including enhancement, delineation, and morphology of the images.

  5. Step 5

    Monitoring for side effects

    After each MRI examination, you will be monitored for any side effects or adverse reactions to the contrast agents. This monitoring period will last for approximately 24 hours after the injection.

    It is important to report any unusual symptoms or discomfort experienced during this time.

  6. Step 6

    Completion of the study

    Once all procedures and evaluations are completed, your participation in the study will conclude.

    The information gathered from your participation will contribute to understanding the effectiveness and safety of the contrast agents used in MRI examinations.

Who can join the trial?

5 criteria

  • Participant must be 18 years of age or older at the time of signing the informed consent form.
  • Participants must have a clinical reason to undergo a contrast-enhanced MRI (Magnetic Resonance Imaging), which is a type of scan that uses a special dye to make certain areas of the body more visible.
  • The MRI should be for any body region except the central nervous system, such as the head and neck, chest, abdomen, pelvis, or limbs.
  • Participants must be able to undergo study-related procedures, including two contrast-enhanced MRI exams: one with the study drug (gadoquatrane) and one with a standard drug (macrocyclic GBCA).
  • Female participants must follow local guidelines for contraception during the study. They must not be pregnant or breastfeeding. They should either be a woman of nonchildbearing potential (cannot become pregnant) or a woman of childbearing potential (can become pregnant) using an acceptable method of birth control during the study and for at least 24 hours after the last dose of the study drug.

Who cannot join the trial?

7 criteria

  • Patients who are allergic to **gadoquatrane** or any similar substances cannot participate. **Gadoquatrane** is a type of contrast agent used in MRI scans.
  • Patients with severe kidney problems are excluded. This is because the kidneys help remove the contrast agent from the body.
  • Pregnant women cannot participate, as the effects of the contrast agent on unborn babies are not fully known.
  • Patients with certain heart conditions may not be eligible, as the contrast agent can affect heart function.
  • Patients who have had a recent MRI with a different contrast agent may need to wait before joining the study.
  • Children under the age of 2 are not eligible to participate in this study.
  • Patients who are unable to undergo an MRI scan for any reason cannot participate. An MRI is a type of scan that uses magnets and radio waves to create images of the inside of the body.
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Investigated drugs

  • Gadoquatrane

    is a new type of contrast agent used in MRI scans. It helps doctors see the inside of your body more clearly by making certain areas stand out in the images. This is especially useful for identifying any problems or diseases in different parts of the body, except the brain and spinal cord. In this study, gadoquatrane is being tested to see if it works as well as other similar contrast agents that are already approved for use.

  • Macrocyclic Gadolinium-Based Contrast Agents (GBCAs)

    are a group of contrast agents commonly used in MRI scans. They contain a substance called gadolinium, which helps to improve the quality of the images taken during the scan. These agents are already approved and widely used to help doctors diagnose various conditions by providing clearer images of the body's internal structures. In this study, they are being used as a comparison to see if the new agent, gadoquatrane, is just as effective.

What is already known about the treatment

Gadoquatrane – Gadoquatrane is administered as an injection for use in magnetic resonance imaging (MRI) to enhance the contrast of images, specifically for assessing conditions outside the central nervous system. It is currently being studied in clinical trials to determine its effectiveness and safety compared to existing gadolinium-based contrast agents. The main therapeutic use of gadoquatrane is to improve the clarity of MRI scans, helping doctors better identify and evaluate potential health issues in various body regions. At the molecular level, gadoquatrane works by altering the magnetic properties of nearby water molecules, which enhances the contrast of the MRI images. It is classified pharmacologically as a gadolinium-based contrast agent.

Investigated diseases

Non-central nervous system pathology – This term refers to diseases or abnormalities that occur outside the central nervous system, which includes the brain and spinal cord. These pathologies can affect various organs and tissues in the body, such as the liver, kidneys, or muscles. The progression of these conditions varies widely depending on the specific disease or abnormality. Some may involve the growth of lesions or tumors, while others might include inflammation or degeneration of tissues. The impact on the body can range from mild to severe, influencing the function of the affected organ or system. Monitoring and assessment often involve imaging techniques to evaluate changes over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501885-24-00Protocol code21197Estimated enrolment664 patientsSponsorBayer AG

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