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Ongoing Clinical Trials for Magnetic Resonance Imaging

Currently, there are 3 ongoing clinical trials focused on testing new contrast agents to improve the quality of MRI scans. These studies are being conducted across multiple European countries and involve both adult and pediatric patients who require contrast-enhanced imaging for various medical conditions.

Clinical trial locations

Study on How Gadoquatrane Works and Its Safety in Children Undergoing MRI Scans

This trial is examining how a new contrast agent called gadoquatrane works in the body and whether it is safe for use in children who need contrast-enhanced MRI scans. The study focuses on understanding how the medication moves through and is cleared from the body after a single injection.

Who can participate:

  • Children from birth to under 18 years old who need a contrast-enhanced MRI scan for a medical reason
  • A legal guardian must provide written consent and be able to accompany the child to study visits
  • Female participants may need pregnancy testing depending on their age and local regulations

Who cannot participate: The trial does not specify detailed exclusion criteria in the available information, but general safety considerations for MRI and contrast agent use would apply.

What the study involves:

Children participating in the study will receive a single intravenous injection of gadoquatrane at a dose of 0.04 mmol per kilogram of body weight. They will then undergo a contrast-enhanced MRI scan. Researchers will monitor how the medication is processed by the body and watch for any side effects within 24 hours after the injection, with continued follow-up for 7 days.

Study drug: The investigational drug is gadoquatrane, a gadolinium-based contrast agent that enhances MRI images by altering the magnetic properties of nearby water molecules, making it easier to see internal body structures more clearly.

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

This trial is evaluating whether a new contrast agent called gadoquatrane works as well as currently approved contrast agents for MRI scans of the brain and spinal cord. The study is designed to compare the quality of images and safety profile between gadoquatrane and other established agents.

Who can participate:

  • Adults 18 years or older who need a contrast-enhanced MRI for known or suspected issues with their brain or spinal cord
  • Must be able to undergo two MRI scans with different contrast agents
  • Female participants must not be pregnant or breastfeeding and must use acceptable birth control during the study and for 24 hours after the last dose

Who cannot participate:

  • People with allergies to contrast agents
  • Those with severe kidney problems
  • Pregnant or breastfeeding women
  • People with a history of severe allergic reactions
  • Those who have had a recent heart attack
  • People with unstable medical conditions
  • Those participating in another clinical trial

What the study involves:

Participants will undergo two MRI scans in a double-blind design, meaning neither they nor the researchers will know which agent is being used during each scan. One scan uses gadoquatrane at a dose of 0.04 mmol per kilogram of body weight, and the other uses one of the approved contrast agents (gadoteric acid, gadobutrol, or gadoteridol) at a dose of 0.1 mmol per kilogram. The images will be evaluated by independent experts to assess quality and effectiveness. Participants will be monitored for side effects for 24 hours after each injection.

Study drugs: The trial tests gadoquatrane against established macrocyclic gadolinium-based contrast agents including gadoteric acid, gadobutrol, and gadoteridol. All are designed to improve the clarity of MRI images of the central nervous system.

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

This trial is investigating whether a new contrast agent called gadoquatrane is as effective and safe as currently approved contrast agents for MRI scans of body areas other than the brain and spinal cord. The study aims to determine if gadoquatrane can be a reliable alternative for imaging various organs and tissues.

Who can participate:

  • Adults 18 years or older who need a contrast-enhanced MRI for any body region except the central nervous system, such as the head and neck, chest, abdomen, pelvis, or limbs
  • Must be able to undergo two MRI scans with different contrast agents
  • Female participants must not be pregnant or breastfeeding and must use acceptable birth control during the study and for 24 hours after the last dose

Who cannot participate:

  • People allergic to gadoquatrane or similar substances
  • Those with severe kidney problems, as the kidneys help remove the contrast agent from the body
  • Pregnant women
  • People with certain heart conditions
  • Those who have had a recent MRI with a different contrast agent
  • Children under 2 years old
  • Anyone unable to undergo an MRI scan for any reason

What the study involves:

Participants will undergo two MRI examinations with different contrast agents administered through intravenous injection. One scan uses gadoquatrane, while the other uses one of the approved agents (gadobutrol, gadoteric acid, or gadoteridol). Independent experts will evaluate the quality of the images, focusing on how well the contrast agents highlight abnormalities. Participants will be monitored for side effects for approximately 24 hours after each injection.

Study drugs: The trial compares gadoquatrane with established macrocyclic gadolinium-based contrast agents including gadoteric acid, gadoteridol, and gadobutrol. These agents help doctors see internal body structures more clearly during MRI scans by improving image contrast.

Summary

All three ongoing trials focus on evaluating gadoquatrane, a new gadolinium-based contrast agent for MRI imaging. The studies are being conducted across eight European countries, with the most comprehensive geographic coverage in Bulgaria, Czechia, Germany, Hungary, and Sweden, where all three trials are taking place.

The trials are designed to cover different patient populations and imaging needs. One study focuses specifically on pediatric patients from birth to 18 years old, while the other two target adults requiring MRI scans for either central nervous system conditions or other body regions. All studies compare gadoquatrane against already approved contrast agents such as gadoteric acid, gadobutrol, and gadoteridol.

A notable feature across all trials is the double-blind comparative design, where participants undergo two MRI scans with different contrast agents. This approach allows for direct comparison of image quality and safety profiles. The monitoring period for side effects is consistently set at 24 hours after injection across all studies, with extended follow-up in the pediatric trial.

These trials represent a comprehensive evaluation program aimed at determining whether gadoquatrane can serve as an effective and safe alternative to existing contrast agents across different age groups and imaging applications.

Ongoing Clinical Trials on Magnetic resonance imaging

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Germany Hungary Italy +1

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Germany Hungary Italy +2

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