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Study of Brain Injury and Concussion Symptoms Using Tau Tracer [18F]RO6958948 in Patients with Traumatic Brain Injury and Hemorrhages

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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 patients with different types of brain injuries and athletes who have symptoms from past concussions. The brain injuries being studied include traumatic brain injury (TBI), intracerebral hemorrhage (ICH), and subarachnoid hemorrhage (SAH). The study uses a special imaging technique called positron emission tomography (PET) to observe the brain. The treatment involves a tracer known as [18F]RO6958948, which is a solution injected into the body to help highlight certain areas of the brain during the PET scan.

The purpose of the study is to see if a protein called tau is increased in the brains of people with these conditions compared to those without brain injuries. The study aims to find out where in the brain this increase happens. Participants will undergo a PET scan, which is a type of imaging test that helps doctors see how the brain is functioning. The tracer, [18F]RO6958948, helps to make the tau protein visible during the scan.

During the study, participants will receive an injection of the tracer and then have a PET scan. This process helps researchers gather information about the presence and location of tau in the brain. The study is designed to improve understanding of brain injuries and concussions, which may lead to better treatments in the future. Participants will be monitored throughout the study to ensure their safety and well-being.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Consent and eligibility

    The patient provides written consent to participate in the study.

    Eligibility is confirmed based on age (18-60 years for patients with brain injury, 18-40 years for athletes) and clinical stability to undergo a PET scan.

    For patients with traumatic brain injury (TBI), intracerebral hemorrhage (ICH), or subarachnoid hemorrhage (SAH), care in an intensive care unit and lack of objection from relatives are required.

    Athletes must have experienced at least one concussion with persistent symptoms for at least 6 months.

  2. Step 2

    Administration of tracer

    The patient receives an injection of a solution containing the tau tracer 18F-RO6958948.

    This tracer is used to visualize areas of the brain during the PET scan.

  3. Step 3

    Positron emission tomography (PET) scan

    The PET scan is conducted to measure the uptake of the tau tracer in the brain.

    The primary objective is to determine if tau levels are increased compared to the normal population and to identify the specific areas of the brain where uptake occurs.

  4. Step 4

    Completion of study participation

    The study participation concludes after the PET scan and data collection.

    The estimated end date for the trial is December 31, 2025.

Who can join the trial?

5 criteria

  • The patient has given their written consent to participate in the study.
  • Age between 18 and 60 years.
  • The patient is considered by the study doctor to be stable enough to undergo a PET scan, which is a special type of imaging test, and can understand the study information.
  • For patients with certain brain conditions like **traumatic brain injury (TBI)**, **intracerebral hemorrhage (ICH)**, or **subarachnoid hemorrhage (SAH)**: They must have been treated in the intensive care unit and their family was informed and did not object to their participation.
  • For athletes aged 18-40 years: They must have had at least one previous concussion during sports and still have ongoing symptoms. These symptoms must have lasted for at least 6 months after the last concussion.

Who cannot join the trial?

4 criteria

  • People who have had a **cerebral commotio**, which is a mild brain injury, cannot participate.
  • Individuals with **intracerebral hemorrhage (ICH)**, which means bleeding inside the brain, are excluded.
  • Those who have experienced a **traumatic brain injury (TBI)**, which is damage to the brain from an external force, are not eligible.
  • Participants with **subarachnoid hemorrhage (SAH)**, which is bleeding in the space around the brain, cannot join the study.
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Investigated drugs

18F-RO6958948 is a special imaging agent used in positron emission tomography (PET) scans. It helps doctors see if there is an increase in tau protein in the brain. This is important for understanding brain injuries and concussion symptoms in athletes. The PET scan with this tracer allows doctors to see where in the brain the tau protein is accumulating, which can provide valuable information for diagnosis and treatment planning.

What is already known about the treatment

18F-RO6958948 – This medication is administered through an injection and is used in positron emission tomography (PET) scans. It is currently being studied in clinical trials to understand its effectiveness in detecting tau protein accumulation in the brain, particularly in conditions like cerebral commotio, intracerebral hemorrhage, traumatic brain injury, and subarachnoid hemorrhage. The main therapeutic indication is to assist in diagnosing and understanding brain injuries by highlighting areas of tau protein build-up. At the molecular level, 18F-RO6958948 binds to tau proteins, allowing them to be visualized during PET scans. It is classified as a radiopharmaceutical used for diagnostic imaging.

Investigated diseases

  • Cerebral commotio

    Also known as a concussion, this condition occurs when the brain is shaken inside the skull due to a blow or impact. It can lead to temporary disruption of brain function, causing symptoms like confusion, headache, dizziness, and sometimes loss of consciousness. The effects are usually temporary, but repeated injuries can lead to more serious issues.

  • Intracerebral hemorrhage (ICH)

    This condition involves bleeding within the brain tissue itself, often caused by high blood pressure or trauma. The bleeding can lead to increased pressure in the brain, resulting in symptoms such as sudden headache, weakness, confusion, and difficulty speaking. The severity and progression depend on the location and amount of bleeding.

  • Traumatic brain injury (TBI)

    This injury results from an external force impacting the head, leading to brain dysfunction. Symptoms can range from mild, such as brief changes in mental status, to severe, including extended periods of unconsciousness or memory loss. The progression varies widely based on the injury's severity and location.

  • Subarachnoid hemorrhage (SAH)

    This condition is characterized by bleeding in the space between the brain and the surrounding membrane, often due to a ruptured aneurysm. It can cause a sudden, severe headache, neck stiffness, and sensitivity to light. The bleeding can lead to increased pressure on the brain, affecting its function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517048-67-00Protocol codeRS200511Estimated enrolment80 patientsSponsorRegion Skane

sourced from the EU Clinical Trials Register and site verification

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