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Vascular Inflammation in Atherosclerosis Whole Body Molecular PET/CT Imaging Using Folate Receptor β

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study investigates inflammation in the blood vessels of people with coronary artery disease (CAD) or a recent myocardial infarction. Inflammation plays an important role in the development and progression of atherosclerosis, but there is currently no established clinical imaging method for detecting inflammation in atherosclerotic plaques throughout the body. The study uses a new PET imaging tracer called 18F-AlF-NOTA-Folate. The tracer is designed to bind to folate receptor beta (FR-β), a marker found on activated macrophages, which are immune cells involved in inflammation. The aim is to determine whether PET imaging with this tracer can detect and measure inflammation in atherosclerotic plaques. Approximately 90 patients will participate. One group will include patients with suspected or stable coronary artery disease who are undergoing coronary CT angiography and PET imaging as part of their clinical assessment. A second, smaller group will include patients who have recently had a myocardial infarction. Participants will undergo PET and CT imaging and provide blood samples. The imaging will examine the coronary arteries and other major arteries, including the carotid arteries, aorta and iliac arteries. The study will also investigate blood flow in the heart and other organs and examine the relationship between vascular inflammation, atherosclerotic plaque characteristics and markers of inflammation in the blood. The study is not testing a treatment for coronary artery disease. The folate tracer is administered only for imaging purposes. Participants will be followed through hospital and registry records for up to five years to investigate whether imaging findings are associated with later cardiovascular events. The study may provide new information about how inflammation is distributed in atherosclerosis and whether FR-β-targeted PET imaging could be useful for detecting and studying vascular inflammation in patients with cardiovascular disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Group A:

• \- Patients aged 50-80 years with suspected coronary artery disease who have undergone coronary CT angiography and are referred for cardiac 15O-water PET perfusion imaging based on suspected obstructive coronary artery disease.

• Group B:

• \- Patients aged 50-80 years with a recent myocardial infarction.

• For both group A and B:

• \- Written informed consent.

Locations
Other Locations
Finland
Turku PET Centre
RECRUITING
Turku
Contact Information
Primary
Antti Saraste, MD, Professor
antsaras@utu.fi
+358-407022756
Time Frame
Start Date: 2026-10-01
Estimated Completion Date: 2032-12
Participants
Target number of participants: 90
Treatments
Experimental: Group A: Chronic/Stable Coronary Artery Disease
Approximately 80 participants with suspected or chronic/stable coronary artery disease and 10 patients with recent myocardial infartion. Participants undergo protocol-defined PET and CT imaging, including 18F-AlF-NOTA-Folate whole-body PET/CT. Participants with CAD also undergo resting 15O-water PET perfusion imaging in addition to clinically indicated stress PET imaging.
Sponsors
Leads: Turku University Hospital

This content was sourced from clinicaltrials.gov