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Study on Water Absorption in the Brain for Adults with Hydrocephalus Using O15-Water

Verified siteInvestigationalNo 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 hydrocephalus, a condition where there is an accumulation of fluid in the brain, leading to increased pressure. The study will use a treatment involving O15-WATER, also known as Oxygen-15 Water or MT-100, which is a solution for injection. This treatment will be administered directly into the brain's ventricles, which are fluid-filled spaces, to assess how well the brain absorbs water in individuals with hydrocephalus.

The purpose of the study is to establish quantitative measures of how the brain absorbs water in patients with hydrocephalus. The study will involve a procedure where O15-WATER is infused into the brain, and the absorption will be measured using imaging techniques like PET/CT, which stands for Positron Emission Tomography and Computed Tomography. This will help researchers understand the water absorption capacity in patients with both communicating and non-communicating types of hydrocephalus.

Participants in the study will undergo the infusion and imaging process to gather data on how their brain handles the injected water. The study aims to develop a model of water absorption in the brain, which could provide valuable insights into the treatment and management of hydrocephalus. The trial is being conducted by Oslo University Hospital and is expected to continue until the end of 2026.

The research process

The trial runs in 7 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 informed about the purpose and procedures involved. The study aims to establish quantitative measures of ventricular water absorption capacity in individuals with hydrocephalus.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have either communicating or non-communicating hydrocephalus.

  3. Step 3

    Preparation for procedure

    Before the procedure, you will receive detailed instructions on how to prepare. This may include fasting or avoiding certain medications.

  4. Step 4

    Administration of solution

    You will receive an injection of a solution called 15-oxygen-water. This solution is administered directly into the brain's ventricles through a method known as intracerebroventricular (ICV) injection.

  5. Step 5

    Imaging and monitoring

    After the injection, you will undergo imaging tests, such as PET/CT scans. These tests help measure how the solution is absorbed in the brain.

  6. Step 6

    Follow-up assessments

    You will have follow-up assessments to monitor your condition and gather additional data. These assessments help establish a model of how water is absorbed in the brain for patients with hydrocephalus.

  7. Step 7

    Completion of study participation

    Once all procedures and assessments are completed, your participation in the study will conclude. You will receive information about any findings related to your health.

Who can join the trial?

5 criteria

  • Must be an adult with **communicating hydrocephalus**. This means the fluid in the brain can flow between different areas but is not absorbed properly.
  • Must be an adult with **non-communicating hydrocephalus**. This means the fluid in the brain is blocked and cannot flow between areas.
  • Must be within the age range of 18 to 64 years old.
  • Both **male** and **female** participants are eligible.
  • Participants should not belong to a vulnerable population, meaning they should not be in a group that needs special protection in research.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with adult hydrocephalus cannot participate. Hydrocephalus is a condition where there is too much fluid in the brain.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

15-oxygen-water is a special type of water used in this clinical trial to study how well the brain absorbs water in patients with hydrocephalus. This water is labeled with a form of oxygen that can be tracked in the body, helping researchers understand the absorption process in the brain's ventricles.

What is already known about the treatment

15-Oxygen-Water – This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating adult hydrocephalus. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication is to assess and measure the absorption capacity of water in the brain's ventricles, which is crucial for understanding and managing hydrocephalus. At the molecular level, it involves tracking the movement and absorption of water molecules labeled with oxygen-15, a radioactive isotope, to provide insights into fluid dynamics within the brain. It falls under the pharmacological classification of diagnostic agents, specifically used for imaging and measurement purposes in medical research.

Investigated diseases

Adult Hydrocephalus – This condition involves an abnormal accumulation of cerebrospinal fluid (CSF) in the brain's ventricles, leading to increased pressure. It can cause symptoms such as difficulty walking, impaired bladder control, and cognitive challenges. The condition may develop gradually, and its progression can vary among individuals. In some cases, it is associated with other conditions like brain injuries or infections. The ventricles may become enlarged, which can be observed through imaging studies. Understanding the dynamics of CSF absorption and flow is crucial in managing this condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519933-53-00Protocol code455136Estimated enrolment100 patientsSponsorOslo University Hospital HF

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