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Evaluation of Brain Inflammation Using 18F-DPA-714 PET Imaging in Patients with Intracerebral Hemorrhage

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Intracerebral Hemorrhage, a condition where bleeding occurs inside the brain tissue. The research uses a special imaging substance called 18F-DPA-714, which is given through an intravenous injection to help understand how inflammation affects the brain after bleeding.

The purpose of this research is to examine how the brain's immune response around the area of bleeding influences a patient's recovery after six months. The study involves receiving a single injection of 18F-DPA-714 approximately 10 days after the brain bleeding occurs. This substance helps create detailed images of inflammation in the brain using a special type of scan called PET (Positron Emission Tomography).

During the study, participants will undergo brain imaging tests, including MRI scans, to examine how the protective barrier of the brain (called the blood-brain barrier) is affected by the bleeding. Blood samples will also be collected to measure various substances that indicate inflammation in the body. Patients will be monitored for six months to track their recovery progress.

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

    Initial brain scan

    You will undergo a brain imaging examination to confirm the presence of intracerebral hemorrhage.

    This examination must take place within 48 hours after the first symptoms appeared.

  2. Step 2

    Pre-inclusion assessment

    Medical staff will perform initial evaluations using two scales:

    The National Institutes of Health Stroke Scale (NIHSS) to assess stroke severity

    The Glasgow Coma Scale to evaluate consciousness level

  3. Step 3

    Special imaging procedures

    Around day 10 (plus or minus 2 days) after the brain bleeding, you will undergo two types of imaging:

    A PET scan using a special substance called 18F-DPA-714, given through an intravenous injection

    An MRI scan to examine the area around the bleeding

  4. Step 4

    Blood sample collection

    Blood samples will be collected around day 10 (plus or minus 2 days) to measure inflammation markers in your blood

  5. Step 5

    14-day monitoring period

    Your condition will be monitored for changes during the first 14 days after the brain bleeding

    Medical staff will regularly check your neurological status using the same scales as in the beginning

  6. Step 6

    30-day assessment

    Your health status will be evaluated at day 30

  7. Step 7

    6-month follow-up

    A final assessment will occur 6 months after the brain bleeding

    Your functional status will be evaluated using the modified Rankin scale, which measures the degree of disability or dependence in daily activities

Who can join the trial?

6 criteria

  • Must be at least 18 years old
  • Must have experienced a spontaneous brain bleeding (spontaneous supratentorial intracerebral hemorrhage) in the upper part of the brain
  • The brain bleeding must have occurred within 48 hours from when symptoms started or when the person was last seen well
  • The brain bleeding must be confirmed by brain imaging (such as CT scan or MRI)
  • Must be able to provide informed consent (agreement to participate in the study after understanding its purpose and procedures)
  • Must have social security coverage or be a beneficiary of a social security scheme

Who cannot join the trial?

15 criteria

  • Age under 18 or over 65 years old
  • Known pregnancy or positive pregnancy test
  • History of previous brain hemorrhage (bleeding in the brain)
  • Current use of blood thinning medications
  • Presence of brain tumors or other severe brain conditions
  • Unable to undergo PET scan (special imaging test) due to medical conditions
  • History of severe allergic reactions to medical contrast agents
  • Unable to provide informed consent
  • Participation in other clinical trials in the past 30 days
  • Severe kidney or liver disease
  • Life expectancy less than 6 months due to other medical conditions
  • Recent major surgery within the past 3 months
  • History of drug or alcohol abuse within the past year
  • Claustrophobia (fear of confined spaces) that would prevent imaging procedures
  • Metal implants or devices that would interfere with imaging studies
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Investigated drugs

18F-DPA-714 is a radioactive tracer used in PET (Positron Emission Tomography) imaging. It helps doctors see inflammation in the brain by binding to specific cells that are active during the inflammatory process. This tracer allows researchers to measure and track inflammation around brain hemorrhages (bleeding) without requiring surgery. It's not a treatment but rather a diagnostic tool that helps understand how inflammation affects recovery after brain bleeding.

What is already known about the treatment

18F-DPA-714 - A specialized radioactive tracer administered intravenously for Positron Emission Tomography (PET) imaging, specifically designed to visualize neuroinflammation in the brain. This diagnostic agent binds to translocator protein (TSPO) receptors that are increased during brain inflammation, allowing doctors to assess inflammatory responses around brain hemorrhages. The tracer is currently used in clinical research to understand the relationship between brain inflammation and patient outcomes after intracerebral hemorrhage, helping medical professionals evaluate the extent of inflammation and blood-brain barrier disruption. Note: While no specific medications are mentioned in the trial data, I provided the description of the radiotracer used in the study since it's a key diagnostic agent in this clinical investigation.

Investigated diseases

Intracerebral hemorrhage - A condition where blood suddenly leaks or spills into the brain tissue, creating a collection of blood that displaces brain tissue. The bleeding occurs when a blood vessel within the brain bursts, often due to high blood pressure or weakened blood vessel walls. As blood collects in the brain, it forms a mass called a hematoma, which can compress brain tissue. The area around the bleeding site typically develops swelling, known as perihematomal edema. The condition can affect various brain functions depending on the location and size of the bleeding.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521923-58-00Estimated enrolment117 patientsSponsorCentre Hospitalier Universitaire De Toulouse

sourced from the EU Clinical Trials Register and site verification

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