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Study of [18F]AlF-NOTA-Octreotide for Carotid Artery Disease in Patients with Recent Stroke or TIA

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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 carotid artery disease, specifically a condition known as carotid artery atherosclerosis. This condition involves the buildup of fatty deposits in the carotid arteries, which can lead to serious health issues like strokes. The study will use a special imaging technique called PET/MRI to look at these arteries. The treatment being tested is a solution for injection called [18F]AlF-NOTA-Octreotide, also known by its code name [18F]-IMP-466. This solution is designed to help doctors see the arteries more clearly during the imaging process.

The purpose of the study is to explore how well [18F]AlF-NOTA-Octreotide works in identifying and measuring the severity of carotid artery disease in patients who have recently experienced a stroke or a mini-stroke, also known as a transient ischemic attack (TIA). Participants in the study will receive an injection of the solution, and then undergo a PET/MRI scan. This scan combines two types of imaging: Positron Emission Tomography (PET), which shows how tissues and organs are functioning, and Magnetic Resonance Imaging (MRI), which provides detailed images of the body's structures.

The study will follow participants over a period of time to see if the imaging results can help predict future health events, such as another stroke or other vascular complications. The goal is to better understand how this imaging technique can be used to assess the risk of these events and improve patient care. Participants will be monitored for any changes in their condition, and the information gathered will help researchers learn more about the potential benefits of using [18F]AlF-NOTA-Octreotide in managing carotid artery disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing voluntary written consent. This consent is necessary before any procedures related to the study can start.
Eligibility requires being over 18 years old and having a recent ischemic stroke or high-risk transient ischemic attack (TIA) in the carotid artery area, with at least 30% narrowing of the carotid artery. The stroke or TIA must have occurred within 21 days before the administration of the tracer.
Step 2
Initial assessment
A computed tomography (CT) angiography is required at the start, which should be part of routine medical care. This imaging helps in assessing the condition of the carotid arteries.
Step 3
Tracer administration
The study involves the use of a tracer called [18F]AlF-NOTA-Octreotide. This is a solution for injection administered through an intravenous bolus injection or infusion.
The purpose of the tracer is to help in the imaging process, which will be used to evaluate the carotid artery disease.
Step 4
Imaging procedure
After the tracer is administered, a PET/MRI scan is conducted. This imaging technique combines positron emission tomography (PET) and magnetic resonance imaging (MRI) to provide detailed images of the carotid arteries.
The goal is to characterize and quantify the atherosclerotic disease in the carotid arteries.
Step 5
Follow-up and monitoring
The study aims to measure the uptake of the tracer in the carotid arteries, which is quantified using a standardized uptake value (SUV).
The study also evaluates the predictive value of the initial plaque SUV for the recurrence of TIA, amaurosis fugax, and stroke over a follow-up period of three years. It also monitors for any vascular complications and all-cause mortality.

Who can join the trial?

6 criteria

The participant must be over 18 years old.
The participant or their legally authorized representative must provide voluntary written informed consent before any screening procedures begin.
A CT angiography image must be available at the start as part of routine care. CT angiography is a special type of X-ray that looks at blood vessels.
The participant must have been diagnosed with a recent **ischemic stroke** or a high-risk **TIA**. An ischemic stroke is when a blood clot blocks a blood vessel in the brain. TIA stands for **transient ischemic attack**, which is like a mini-stroke that doesn't cause permanent damage. The TIA must have a score of 4 or more on the **ABCD2** scale, which is a way to measure the risk of having a stroke after a TIA.
The stroke or TIA must have happened in the **carotid artery** area, which is a major blood vessel in the neck, and there must be at least 30% **stenosis**. Stenosis means narrowing of the artery.
The stroke or TIA must have occurred no more than 21 days before the tracer is given. A tracer is a substance used in medical imaging to help see certain areas of the body.

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Katholieke Universiteit te Leuven
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Leuven, Belgium

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Investigated drugs

[18F]AlF-NOTA-octreotide is a special imaging agent used in this study. It helps doctors see inside the body using a PET/MRI scan. This agent is designed to attach to certain areas in the carotid arteries, which are the main blood vessels in the neck that supply blood to the brain. By using this imaging agent, doctors can get a clearer picture of any disease or blockages in these arteries, especially in patients who have recently had a stroke or a transient ischemic attack (TIA).

[18F]Alf-Nota-Octreotide

What is already known about the treatment

[18F]AlF-NOTA-octreotide – This medication is administered through a PET/MRI scan, where it is used as a radiotracer to help visualize certain conditions. Currently, it is being explored in clinical trials for its potential to assess carotid artery atherosclerosis, particularly in patients who have experienced a recent stroke or transient ischemic attack (TIA). The main therapeutic indication is to aid in the characterization and quantification of atherosclerotic disease in the carotid arteries. At the molecular level, it works by binding to specific receptors that are often overexpressed in atherosclerotic plaques, allowing for detailed imaging. It falls under the pharmacological classification of radiopharmaceuticals, which are used in diagnostic imaging.

Investigated diseases

Carotid artery atherosclerosis – This condition involves the buildup of fatty deposits, known as plaques, in the carotid arteries, which are the major blood vessels in the neck that supply blood to the brain. Over time, these plaques can harden and narrow the arteries, reducing blood flow to the brain. This process can lead to symptoms such as transient ischemic attacks (TIAs) or strokes if the blood supply is significantly reduced or blocked. The progression of the disease is typically slow, occurring over many years, and may not present noticeable symptoms until the arteries are significantly narrowed. Factors such as high cholesterol, high blood pressure, smoking, and diabetes can accelerate the development of atherosclerosis. Regular monitoring and lifestyle changes can help manage the progression of the disease.