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Study on Gadobutrol for Patients with Idiopathic Normal Pressure Hydrocephalus to Understand Cerebrospinal Fluid Movement Using MRI

Fast replyRegistered 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 studying a condition known as idiopathic normal pressure hydrocephalus (INPH), which is a disorder related to the circulation of cerebrospinal fluid in the brain. The study will use a medication called Gadovist, which is a solution for injection containing the active substance gadobutrol. This medication is used as a contrast agent in MRI scans to help visualize the transportation of cerebrospinal fluid in the brain.

The purpose of the study is to understand how the contrast agent distributes and is eliminated in the body, as observed through repeated MRI scans. The study will also monitor any side effects that may occur from the administration of Gadovist. Participants will receive an injection of the contrast agent into the spinal canal, and then undergo a series of MRI scans to track the movement and clearance of the contrast in the brain.

Throughout the study, researchers will analyze changes in the MRI images to gain insights into the dynamics of cerebrospinal fluid movement. This information could help improve understanding of the condition and potentially lead to better treatment options for patients with INPH. The study will also compare the distribution of the contrast agent with other MRI sequences and fluid dynamics parameters to explore possible mechanisms driving the distribution of cerebrospinal fluid.

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 assessed to ensure you meet the criteria for participation. This involves confirming that you are being investigated for suspected idiopathic normal pressure hydrocephalus.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to gather baseline information. This may include a review of your medical history and any necessary preliminary tests.

  3. Step 3

    Administration of contrast agent

    You will receive an injection of a contrast agent called Gadovist into the spinal canal. This is known as intrathecal use, meaning the injection is administered into the space around your spinal cord.

    The purpose of this contrast agent is to help visualize the transportation of cerebrospinal fluid in your brain during MRI scans.

  4. Step 4

    MRI scans

    After the administration of the contrast agent, you will undergo a series of MRI scans. These scans will be repeated at different times to observe how the contrast agent moves and is eliminated from your body.

    The MRI scans are non-invasive and will help in understanding the distribution and rate of elimination of the contrast agent.

  5. Step 5

    Monitoring for adverse events

    Throughout the trial, you will be monitored for any possible adverse events related to the injection of Gadovist. This is to ensure your safety and to document any side effects that may occur.

  6. Step 6

    Completion of the trial

    Once all necessary data has been collected and you have completed the required MRI scans, your participation in the trial will conclude.

    You will be informed of any follow-up procedures or additional information that may be relevant to your health.

Who can join the trial?

3 criteria

  • Patients must be investigated for suspected idiopathic normal pressure hydrocephalus. This is a condition where there is a problem with the flow of the fluid around the brain and spinal cord.
  • Both men and women can participate in the study.
  • Participants must be adults, which means they are 18 years or older.

Who cannot join the trial?

5 criteria

  • Patients with a disorder in the circulation of the cerebrospinal fluid, which is the fluid surrounding the brain and spinal cord, cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not comfortable with undergoing repeated MRI scans, which are imaging tests that use magnets and radio waves to create pictures of the inside of the body, cannot participate.
  • Patients who have had adverse reactions to Gadovist, a contrast agent used in MRI scans to improve the clarity of the images, cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Gadovist is a contrast agent used in this clinical trial. It is a special dye that helps doctors see the flow of cerebrospinal fluid in the brain and spine more clearly during an MRI scan. The purpose of using Gadovist in this study is to measure how the dye spreads and how quickly it is removed from the body. This information can help doctors understand how well the cerebrospinal fluid is moving, which is important for diagnosing and treating certain medical conditions. The study will also monitor for any side effects that might occur from using Gadovist.

What is already known about the treatment

Gadovist – Gadovist is administered through an injection into the spinal canal, a method known as intrathecal administration. It is currently being studied in clinical trials to understand its role in cerebrospinal fluid circulation disorders, particularly in cases suspected of idiopathic normal pressure hydrocephalus. The main therapeutic use of Gadovist in this context is to enhance MRI imaging, allowing doctors to see how the fluid moves and is eliminated in the brain. At the molecular level, Gadovist works by altering the magnetic properties of nearby water molecules, which improves the contrast of MRI images. It is classified as a contrast agent in pharmacology, specifically used to improve the clarity of MRI scans.

Investigated diseases

Idiopathic Normal Pressure Hydrocephalus – This condition involves an abnormal buildup of cerebrospinal fluid in the brain's ventricles, which are fluid-filled spaces. Despite the increased fluid, the pressure inside the brain remains normal, which is why it is termed "normal pressure." The excess fluid can lead to swelling of the ventricles, which may affect nearby brain tissue. As the condition progresses, it can cause symptoms such as difficulty walking, memory problems, and urinary incontinence. The exact cause of the fluid buildup is unknown, and it is often seen in older adults. The progression of symptoms can vary, and they may develop slowly over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-520146-33-00Estimated enrolment135 patientsSponsorRegion Vaesterbotten

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