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Study of Gadobutrol for MRI in Adults with Cerebrospinal Fluid Disorders, Including Hydrocephalus and Brain Tumors

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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 several conditions related to the brain and spinal fluid, including communicating hydrocephalus, primary malignant brain tumor, intracranial cysts, Chiari malformation, idiopathic intracranial hypotension, idiopathic intracranial hypertension, and conditions following a subarachnoid hemorrhage. The study uses a special type of MRI (magnetic resonance imaging) contrast agent called gadobutrol, which is a gadolinium-based contrast agent (GBCA). This agent is administered into the spinal canal to help visualize the flow and clearance of fluids in the brain.

The purpose of the study is to better understand how the contrast agent moves within the brain. This helps in assessing where there might be blockages in the flow of cerebrospinal fluid and how quickly substances are cleared from the brain. Participants will receive the contrast agent through a procedure called intrathecal use, which means it is injected into the space around the spinal cord. After the injection, MRI scans will be performed to track the distribution and intensity of the contrast agent over time.

The study aims to provide valuable insights into the treatment and management of these brain and spinal fluid conditions by observing changes in the MRI signal after the contrast is administered. This information could potentially lead to improved diagnostic and therapeutic strategies for patients with these 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

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. Conditions such as communicating hydrocephalus, idiopathic intracranial hypertension, idiopathic intracranial hypotension, intracranial cysts, primary malignant brain tumor, and post-subarachnoid hemorrhage are considered for participation.

  2. Step 2

    Administration of contrast agent

    The contrast agent gadobutrol is administered via intrathecal use, which means it is injected into the spinal canal. This is done to enhance the magnetic resonance imaging (MRI) of the brain.

  3. Step 3

    MRI procedure

    Following the administration of the contrast agent, an MRI is performed. The objective is to visualize the distribution of the contrast within the brain. This helps in assessing the location of any obstruction in the flow of cerebrospinal and interstitial fluid, as well as the rate of clearance of solutes from the cerebrospinal fluid and brain.

  4. Step 4

    Monitoring signal intensity

    The primary endpoint of the trial is to observe the time-dependent change in signal intensity on the brain MRI after the intrathecal contrast administration. This involves monitoring how the signal changes over time.

  5. Step 5

    Regional differences analysis

    The secondary endpoint involves analyzing time-dependent regional differences in signal intensity on the brain MRI. This helps in understanding how different regions of the brain respond to the contrast agent over time.

  6. Step 6

    Completion of trial

    The trial is estimated to conclude by December 31, 2026. Participants will be informed of the results and any relevant findings related to their condition.

Who can join the trial?

4 criteria

  • Must have one of the following conditions: Communicating hydrocephalus, Idiopathic intracranial hypertension (a condition where there is high pressure inside the skull without a known cause), Idiopathic intracranial hypotension (a condition where there is low pressure inside the skull without a known cause), Intracranial cysts (fluid-filled sacs inside the skull), Primary malignant brain tumor (a cancerous growth in the brain that started there), or Post-subarachnoid hemorrhage (a condition following bleeding in the space around the brain).
  • Participants can be both male and female.
  • Participants must be within the age range of children and adults.
  • Participants should not belong to a vulnerable population.

Who cannot join the trial?

7 criteria

  • Having a condition called communicating hydrocephalus, which is a type of brain fluid buildup.
  • Having a primary malignant brain tumor, which is a cancerous growth in the brain.
  • Having intracranial cysts, which are fluid-filled sacs inside the skull.
  • Having a Chiari malformation, a condition where brain tissue extends into the spinal canal.
  • Having idiopathic intracranial hypotension, which is low pressure of the fluid around the brain for unknown reasons.
  • Having idiopathic intracranial hypertension, which is high pressure of the fluid around the brain for unknown reasons.
  • Having had a post subarachnoid hemorrhage, which is bleeding in the space around the brain.
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Investigated drugs

Intrathecal Contrast Agent is used in this trial to enhance magnetic resonance imaging (MRI) scans. It is injected into the space around the spinal cord to help visualize the distribution of the contrast within the brain. This helps doctors see if there are any blockages in the flow of fluids in the brain and how quickly substances are cleared from the brain and cerebrospinal fluid.

What is already known about the treatment

Intrathecal Contrast Agent – This medication is administered through an injection into the spinal canal, allowing it to mix with cerebrospinal fluid. It is currently being studied in clinical trials to enhance magnetic resonance imaging (MRI) for better visualization of brain conditions. The main therapeutic indications include conditions like communicating hydrocephalus, primary malignant brain tumors, intracranial cysts, Chiari malformation, idiopathic intracranial hypotension, idiopathic intracranial hypertension, and post subarachnoid hemorrhage. The mechanism of action involves enhancing the contrast in MRI images, which helps in assessing the flow and clearance of fluids in the brain. It is classified as a diagnostic imaging agent.

Investigated diseases

  • Communicating hydrocephalus

    This condition occurs when there is an imbalance between the production and absorption of cerebrospinal fluid, leading to its accumulation in the brain's ventricles. It can cause increased pressure inside the skull, potentially leading to symptoms like headaches, nausea, and balance problems. Over time, it may affect cognitive functions and coordination.

  • Primary malignant brain tumor

    This refers to a cancerous growth that originates in the brain. These tumors can grow rapidly and invade surrounding brain tissue, potentially causing symptoms such as headaches, seizures, and changes in behavior or cognition. The progression can vary depending on the type and location of the tumor.

  • Intracranial cysts

    These are fluid-filled sacs that can develop in various parts of the brain. While they are often benign, their presence can lead to symptoms if they press on brain structures, potentially causing headaches, nausea, or neurological deficits. The size and location of the cysts influence the symptoms experienced.

  • Chiari malformation

    This structural defect involves the displacement of brain tissue into the spinal canal. It can disrupt the normal flow of cerebrospinal fluid, leading to symptoms such as headaches, neck pain, and balance issues. In some cases, it may also affect coordination and motor skills.

  • Idiopathic intracranial hypotension

    This condition is characterized by low pressure of cerebrospinal fluid within the skull, often due to a leak. It can cause symptoms like severe headaches, neck stiffness, and nausea, which may worsen when standing and improve when lying down. The exact cause is often unknown.

  • Idiopathic intracranial hypertension

    This condition involves increased pressure inside the skull without an obvious cause. It can lead to symptoms such as headaches, vision problems, and ringing in the ears. The condition is more common in young women and can affect daily activities.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519936-18-00Protocol code2015/96 MRI contrastEstimated enrolment1 000 patientsSponsorOslo University Hospital HF

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