In short
AL[18F]F-NOTA-FOLATE is an investigational radioactive tracer being studied for PET imaging. It targets the folate receptor, which is found on activated macrophages involved in inflammation. Currently, one authorised Phase 1/2 trial is evaluating this tracer in 143 participants with suspected cardiac sarcoidosis or infective endocarditis, as well as in healthy volunteers.
Key points
- AL[18F]F-NOTA-FOLATE is an investigational radioactive tracer for PET imaging.
- The ongoing trial is Phase 1/2 and has been authorised.
- It plans to enrol 143 participants, including patients and healthy volunteers.
- The study focuses on cardiac sarcoidosis and infective endocarditis.
- The main goal is to measure tracer uptake in the heart using PET scans.
- The tracer is given as an intravenous injection.
What is AL[18F]F-NOTA-FOLATE?
AL[18F]F-NOTA-FOLATE is an investigational radioactive tracer, also called a radiotracer. It is being developed for use with positron emission tomography (PET), an imaging method that shows where a radioactive substance collects in the body. The substance is a folate derivative labelled with fluorine-18, a radioactive form of fluorine. It is not an authorised medicine; it is being studied in clinical trials.
How does AL[18F]F-NOTA-FOLATE work?
The tracer is designed to attach to the folate receptor, a protein found on the surface of certain cells, including activated macrophages. Macrophages are immune cells that become active during inflammation. When the tracer binds to these cells, the attached radioactive fluorine-18 can be detected by a PET scanner. This may help show areas of active inflammation in the body.
Which conditions is AL[18F]F-NOTA-FOLATE studied for?
- Cardiac sarcoidosis: a rare condition where clusters of inflammatory cells form in the heart, potentially affecting its rhythm and function.
- Infective endocarditis: an infection of the inner lining of the heart or heart valves, which can be life-threatening and is sometimes hard to diagnose.
How is AL[18F]F-NOTA-FOLATE given?
AL[18F]F-NOTA-FOLATE is given as an intravenous injection, meaning it is injected directly into a vein. The injection is followed by a PET scan to detect where the tracer has accumulated in the body.
What do the clinical trials show?
One clinical trial is currently authorised for this substance. It is a Phase 1/2 trial, which means it is an early-stage study looking at both safety and initial signs of how well the tracer works. The trial plans to enrol 143 participants, including patients with suspected cardiac sarcoidosis, patients with suspected infective endocarditis, and healthy volunteers.
The main measurement in the trial is the quantitative uptake of the tracer in specific areas of the heart. For cardiac sarcoidosis, researchers will measure uptake in the left ventricular myocardium, the main pumping muscle of the heart. For infective endocarditis, they will measure uptake in the heart valves or in the regions around prosthetic (artificial) valves.
Healthy volunteers are included to provide comparison values for normal tracer uptake. The trial is currently authorised, meaning it has received regulatory approval to begin, though it may not yet have started recruiting participants.