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

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What is this study about?

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.

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 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 preparation for procedure

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

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.05.2023

Trial locations

Investigated drugs:

O15-Water

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.

Investigated diseases:

Hydrocephalus

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 ID:

2024-519933-53-00

Protocol code:

455136

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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