AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients with Suspected Cardiac Sarcoidosis or Infective Endocarditis and Healthy Volunteers (FOL-CARD)

Doctors are testing a new radioactive dye used during PET scans to improve how heart conditions are diagnosed. The trial looks at two serious conditions: cardiac sarcoidosis (an inflammatory disease of the heart muscle) and infective endocarditis (a bacterial infection of the heart valves). Both conditions can be difficult to diagnose with standard hospital tests. This early-stage study is the first time this specific scanning dye is being given to humans. Researchers want to find out how safe it is, how it travels through the body, and whether it highlights inflamed or infected heart tissue accurately. The study also includes healthy volunteers to compare normal scan results with those of people with suspected heart conditions. Taking part involves having a specialised scan and health checks. It aims to help doctors detect heart inflammation sooner and guide better treatment in the future.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Turku University Hospital

Enrolment target

143

Start

24 Aug 2026

Cardiac Sarcoidosis, Infective endocarditis

What is this study about?

Cardiac sarcoidosis and infective endocarditis are two conditions that cause inflammation or infection in the heart. In cardiac sarcoidosis, the body's immune system mistakenly forms tiny lumps of cells in the heart muscle. In infective endocarditis, germs settle on the heart valves, causing damage. Both problems can cause chest pain, breathlessness, irregular heartbeats, and fatigue. Finding these conditions early is vital, but current scans can sometimes miss them or produce unclear pictures.

In this trial, called FOL-CARD, scientists are testing a new scanning dye called Al[18F]F-NOTA-folate. This dye is designed to attach to specific immune cells that gather at areas of inflammation and infection. When patients have a PET scan (a detailed type of 3D body scan), the dye should 'light up' the affected parts of the heart, showing doctors exactly where the problem is located.

Because this is an early-stage study (Phase I and II), it is the first time this dye is being used in people. Researchers want to check how safe it is, measure the small dose of radiation received, and see how well it works. They also want to see if scan results improve after patients receive standard treatment, such as medicines that calm the immune system.

If successful, this new scanning method could give doctors a quicker, clearer way to diagnose serious heart conditions. Better scans mean patients can start the right treatments sooner, preventing long-term damage to the heart.

Key takeaways

Tests a new scanning dye to detect heart inflammation and infection.
First time this specific dye is being used in people (Phase I/II trial).
Open to adults aged 18+ with suspected heart conditions and healthy volunteers.
Involves a PET scan, health checks, and careful safety monitoring.
Completely voluntary, with no changes to your regular medical treatment.

Who may be eligible?

This study is open to adults aged 18 and older. Researchers are looking for two groups of people: patients who are suspected of having either cardiac sarcoidosis or infective endocarditis, and healthy volunteers who do not have these heart conditions.

If you have suspected heart inflammation or a valve infection, your hospital team will usually check whether this trial is suitable alongside your usual care. Healthy volunteers are needed so researchers can see what a normal, healthy heart looks like with the new scan and check how the dye behaves in the body.

Certain people may not be able to take part. For example, people who are pregnant, breastfeeding, or who cannot safely have a PET scan may be excluded. The study team will review your full medical history before you join to ensure it is completely safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have suspected cardiac sarcoidosis, or...
I have suspected infective endocarditis, or...
I am interested in joining as a healthy volunteer.
I am able to lie still in a scanner for up to an hour.

Answer every question to see your result.

What does participation involve?

Taking part usually involves visiting a hospital imaging centre for one or more appointments. Before any tests, a doctor will explain the study, check your health, and ask you to sign a consent form. On the day of your scan, you will have a small cannula (a thin plastic tube) placed into a vein in your arm. The study dye is injected through this tube. After waiting a short time for the dye to circulate, you will lie still inside a PET scanner while it takes pictures of your heart. The scan itself is painless and typically takes under an hour. You may also have blood tests and checks of your blood pressure and heart rate. Some patients with sarcoidosis may be asked to return for a second scan after starting treatment to see if their inflammation has gone down. The study team will monitor you for any side effects before you go home.

Potential risks and benefits

You may not get any direct medical benefit from joining this study, although your scan results could provide helpful information about your heart health. The main value is helping researchers develop better scans for future NHS patients. The risks include minor bruising or discomfort from the blood test or cannula. The scanning dye contains a small, carefully controlled dose of radiation, similar to other standard hospital scans. Because this dye is being tested in humans for the first time, there is a small chance of unexpected side effects or mild allergic reactions. Your safety is monitored closely throughout, and you can leave the study at any time without it affecting your regular NHS medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is a PET scan?

A PET scan is a safe, painless hospital scan that produces 3D pictures of the inside of your body using a tiny amount of a radioactive liquid called a tracer.

Will having this scan hurt?

No. The scan itself is completely painless. You will only feel a quick pinch when the small needle is placed in your arm to give the scanning dye.

Why are healthy volunteers needed?

Healthy volunteers give doctors a clear baseline. By seeing how the dye acts in a healthy heart, doctors can easily spot what is different in an inflamed or infected heart.

Will taking part replace my usual heart treatment?

No. This trial is for diagnostic imaging only. You will continue to receive all your standard medical treatments as advised by your cardiology team.

Can I leave the study if I change my mind?

Yes. Taking part is entirely voluntary. You can stop participating at any point, and you do not need to give a reason. Your normal NHS care will continue as usual.