Study on Brain Inflammation in Stroke Patients Using Ficolin-2, Gadoteric Acid, and 18F-DPA-714

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What is this study about?

This clinical trial is focused on studying inflammation in the brain and blood vessels in patients who have experienced a stroke or a transient ischemic attack (often called a mini-stroke). The study is particularly interested in a condition known as carotid stenosis, which is a narrowing of the carotid arteries that supply blood to the brain. The trial will use a special imaging technique called PET/MRI to look at inflammation in the brain and carotid arteries. Two substances will be used in this study: Gadoteric Acid, which is a type of contrast used in imaging, and 18F-DPA-714, a compound that helps highlight inflammation during the imaging process.

The purpose of the study is to explore the relationship between levels of a protein called ficolin-2 in the blood and inflammation in the brain and carotid arteries. Participants will undergo imaging with PET/MRI to assess inflammation. The study will involve taking blood samples to measure ficolin-2 levels and performing imaging tests to observe the condition of the carotid arteries and brain. The imaging will help identify features such as the size of any brain infarcts (areas of tissue damage due to lack of blood flow) and any changes in the carotid arteries, such as the presence of bleeding within the artery walls or damage to the protective layer of the artery.

Throughout the study, participants will have their blood tested and undergo imaging at specific times to monitor changes. The study aims to provide insights into how ficolin-2 levels relate to inflammation in the brain and carotid arteries, which could help improve understanding and treatment of conditions like stroke and transient ischemic attack. The trial is expected to continue until the end of 2024.

1 joining the study

Upon joining the study, you will be required to provide a signed written informed consent. This is a document that confirms your agreement to participate in the study after understanding all the details and potential risks involved.

2 initial assessment

You will undergo an initial assessment to confirm your eligibility. This includes verifying that you are 18 years or older and have experienced a probable transient ischemic attack (TIA) or ischemic stroke within the last 24 hours. Additionally, the presence of atherosclerotic carotid stenosis between 50% and 99% will be confirmed through imaging tests such as Doppler ultrasound, MR angiography, CT angiography, or catheter angiography.

3 medication administration

During the trial, you will receive two types of medications: gadoteric acid and 18F-DPA-714. These will be administered through an injection into your vein (intravenous use). The specific dosage and frequency will be determined by the study team based on your individual needs.

4 imaging and blood tests

On day 5 of the trial, you will undergo a PET/MRI scan. This imaging test will help assess inflammation in your carotid arteries and brain. Additionally, a blood sample will be taken to measure the levels of a protein called ficolin-2 in your plasma.

5 follow-up assessments

Further assessments will be conducted on day 15. These will include additional blood tests to measure ficolin-2 levels and evaluations of morphological data from the imaging tests. The results will help determine the presence of specific conditions such as intraplaque hemorrhage and infarct size.

6 completion of the trial

The trial is expected to conclude by December 1, 2024. Upon completion, you will receive information about the findings and any relevant follow-up care that may be necessary.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must provide signed written informed consent before any study-specific procedures.
Patients must have had a probable ipsilateral transient ischemic attack (TIA) or an ischemic stroke within 24 hours from the onset. A TIA involves a temporary problem with speech, movement, or vision that lasts less than 24 hours and is related to a carotid artery.
Patients must have atherosclerotic carotid stenosis between 50% and 99%. This means there is a narrowing of the carotid artery due to plaque buildup, confirmed by imaging tests like Doppler ultrasound, MR angiography, CT angiography, or catheter angiography after the TIA or stroke.

Who Cannot Join the Study?

Patients who have had a stroke or transient ischemic attack (a temporary blockage of blood flow to the brain) cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hospices Civils De Lyon	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

[18F]DPA-714 is a special type of imaging agent used in this clinical trial. It helps doctors see inflammation in the brain and carotid arteries using a PET/MRI scan. This imaging agent is particularly useful for patients who have had a transient ischemic attack or an acute ischemic stroke due to carotid stenosis. By using this agent, doctors can better understand the level of inflammation in these areas, which is important for assessing the patient’s condition and planning further treatment.

Investigated diseases:

Transient Ischemic Attack – A transient ischemic attack (TIA) is a temporary period of symptoms similar to those of a stroke. It occurs when there is a brief interruption in the blood supply to part of the brain. This interruption can cause sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. The symptoms usually last for a few minutes to a few hours and then resolve completely. Unlike a stroke, a TIA does not cause permanent damage to the brain. It is often considered a warning sign of a potential future stroke.

Acute Ischemic Stroke – An acute ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a sudden loss of blood flow. This blockage prevents oxygen and nutrients from reaching brain tissue, leading to the death of brain cells. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. Other symptoms may involve vision problems, dizziness, or loss of balance and coordination. The effects of an ischemic stroke can vary widely depending on the location and extent of the brain affected. Immediate medical attention is crucial to minimize brain damage and improve outcomes.

Trial ID:

2023-504573-20-00

Protocol code:

69HCL20_0403

NCT ID:

NCT05850247

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Brain Inflammation in Stroke Patients Using Ficolin-2, Gadoteric Acid, and 18F-DPA-714

What is this study about?

Who Can Join the Study?

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