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[18F]Alf-Nota-Octreotide

This article provides information about a clinical trial using [18F]Alf-Nota-Octreotide, a specialized imaging agent, in combination with PET/MRI scanning. The study aims to investigate carotid artery disease in patients who have recently experienced a stroke or transient ischemic attack (TIA). The trial seeks to evaluate how this innovative imaging technique can help characterize and quantify atherosclerosis in the carotid arteries, potentially improving our understanding of stroke risk and patient care.

Table of Contents

What is [18F]ALF-NOTA-OCTREOTIDE?

[18F]ALF-NOTA-OCTREOTIDE, also known as [18F]-IMP-466, is a new imaging agent being studied for use in medical imaging[1]. It is a solution that is injected into the body to help doctors see certain parts of the body more clearly during a special type of scan called PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging).

How is [18F]ALF-NOTA-OCTREOTIDE Used?

This imaging agent is given as an intravenous bolus injection or IV infusion. This means it’s injected directly into a vein, either as a quick injection (bolus) or as a slower infusion[1]. The maximum dose used in the study is 50 micrograms, which is a very small amount[1].

What Medical Conditions Does It Help With?

The current study is focusing on using [18F]ALF-NOTA-OCTREOTIDE to help with carotid artery atherosclerosis[1]. This is a condition where the carotid arteries, which are major blood vessels in the neck that supply blood to the brain, become narrowed due to the buildup of plaque. This condition can increase the risk of stroke.

Details of the Current Study

Researchers are conducting a Phase II clinical trial to explore how well [18F]ALF-NOTA-OCTREOTIDE works in imaging carotid artery disease[1]. This study is specifically looking at patients who have recently had a stroke or a transient ischemic attack (TIA), which is sometimes called a “mini-stroke”.

The study aims to see if this new imaging agent can help doctors:

  • Better understand the characteristics of carotid artery disease
  • Measure how severe the disease is
  • Identify patients who might be at higher risk of having another stroke

Who Can Participate in the Study?

The study has specific criteria for who can participate. Here are some key points[1]:

Inclusion Criteria (who can join):

  • People over 18 years old
  • Those who have had a recent ischemic stroke or high-risk TIA in the carotid artery area within the last 21 days
  • Patients with at least 30% narrowing (stenosis) of the carotid artery

Exclusion Criteria (who cannot join):

  • Pregnant or breastfeeding women
  • People who have had certain types of strokes not related to carotid artery disease
  • Those who have had recent carotid artery surgery or stenting
  • People who can’t have an MRI scan
  • Individuals with severely reduced kidney function
  • Those taking corticosteroids or somatostatin analogues

What Are the Goals of the Study?

The main goals of this study are[1]:

  1. To measure how much [18F]ALF-NOTA-OCTREOTIDE is taken up by the affected carotid artery and compare it to the unaffected side.
  2. To see if the amount of [18F]ALF-NOTA-OCTREOTIDE taken up by the artery can predict the risk of future strokes or other vascular problems.

Researchers will follow participants for 3 years to see if there’s a link between the imaging results and future health outcomes.

Aspect Details
Study Type Phase II clinical trial, single-center prospective study
Main Objective Evaluate [18F]Alf-Nota-Octreotide PET/MRI in characterizing carotid atherosclerotic disease
Secondary Objective Identify risk for ipsilateral recurrent stroke in patients with ≥30% carotid artery stenosis
Key Inclusion Criteria Adults over 18, recent ischemic stroke or high-risk TIA, ≥30% carotid artery stenosis
Key Exclusion Criteria Pregnancy, certain stroke types, recent carotid surgeries, MRI contraindications
Primary Endpoint Quantification of [18F]Alf-Nota-Octreotide uptake in carotid arteries using SUV
Secondary Endpoint Predictive value of plaque SUV for recurrence of stroke/TIA and other vascular events
Follow-up Period 3 years
Drug Information [18F]Alf-Nota-Octreotide, solution for injection, max daily dose 50 μg
Administration Route Intravenous bolus injection/IV infusion

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this trial is to evaluate the potential of [18F]Alf-Nota-Octreotide PET/MRI in characterizing and quantifying carotid atherosclerotic disease in patients who have recently experienced a stroke or TIA.
  • Who is eligible to participate in this study? Eligible participants are adults over 18 years old who have been diagnosed with a recent ischemic stroke or high-risk TIA in the carotid artery territory, with at least 30% carotid artery stenosis. The stroke or TIA should have occurred no more than 21 days before the study.
  • What is [18F]Alf-Nota-Octreotide and how is it used in this trial? [18F]Alf-Nota-Octreotide is a specialized imaging agent used in PET/MRI scans. In this trial, it is administered as a solution for injection to help visualize and measure the extent of carotid artery disease.
  • What are some reasons why someone might not be able to participate in this study? Exclusion criteria include pregnancy, breastfeeding, certain types of strokes, recent carotid surgeries, inability to undergo MRI scanning, impaired renal function, and concurrent treatment with corticosteroids or somatostatin analogues.
  • What will researchers measure during this study? The primary measurement will be the uptake of [18F]Alf-Nota-Octreotide in the affected and unaffected carotid arteries using standardized uptake value (SUV). They will also assess how well this measurement predicts future stroke or TIA events over a 3-year follow-up period.

Ongoing Clinical Trials on [18F]Alf-Nota-Octreotide

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

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • PET/MRI: A combined imaging technique that uses both Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) to create detailed images of the body's structures and functions.
  • Carotid artery atherosclerosis: A condition where fatty deposits (plaques) build up in the carotid arteries, which supply blood to the brain, potentially leading to reduced blood flow or stroke.
  • Transient Ischemic Attack (TIA): Often called a 'mini-stroke', a TIA is a temporary period of symptoms similar to a stroke, typically lasting only a few minutes and causing no permanent damage.
  • Stenosis: The narrowing of a blood vessel, in this case, the carotid artery, which can restrict blood flow to the brain.
  • Standardized Uptake Value (SUV): A measurement used in PET imaging to quantify the concentration of radioactive tracer in a specific area of the body.
  • Ischemic stroke: A type of stroke caused by a blockage in an artery supplying blood to the brain, resulting in a lack of oxygen to brain tissue.
  • ABCD2 score: A clinical assessment tool used to estimate the risk of stroke after a TIA, considering factors such as age, blood pressure, and symptom duration.
  • Culprit carotid artery: The carotid artery responsible for causing the stroke or TIA symptoms in a patient.
  • Ipsilateral: Occurring on or affecting the same side of the body.
  • Amaurosis fugax: A temporary loss of vision in one eye, often described as a 'curtain' coming down over the eye, which can be a warning sign of carotid artery disease.

References

  1. http://clinicaltrials.eu/trial/study-of-18falf-nota-octreotide-for-carotid-artery-disease-in-patients-with-recent-stroke-or-tia/