Diagnostic PET Study of Al[18F]F-NOTA-folate in Patients with Suspected Cardiac Sarcoidosis or Infective Endocarditis

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What is this study about?

The study looks at two heart‑related conditions: Cardiac Sarcoidosis, a disease where inflammatory cells form small clumps in the heart muscle, and Infective endocarditis, an infection that can affect the heart valves or artificial valve devices. Participants will receive an Al[18F]F-NOTA-folate test agent, which is given by an intravenous injection (a medicine placed directly into a vein) and then examined with a special imaging scan.

The purpose of the study is to evaluate how much of the test agent is taken up by the heart tissue in these conditions. After the injection, a PET scan (a type of picture that shows where a radioactive substance goes inside the body) is performed to see the distribution of the agent in the heart muscle or valve areas. Some participants with suspected disease may have a second scan after receiving standard anti‑inflammatory treatment, while healthy volunteers undergo a single scan to understand normal distribution and safety.

1 initial visit and consent

you attend the first appointment after being accepted into the study.

the study team explains the purpose of the trial, what will happen, and any possible risks.

you sign a consent form indicating that you agree to take part.

2 baseline assessments

your medical history, current medications, and basic laboratory tests are recorded.

these data help the researchers understand your health status before any study procedures.

3 first al[18f]f-nota-folate injection and pet scan

on the scheduled day you go to the imaging center.

a small amount of al[18f]f-nota-folate is given to you through an intravenous injection (a needle placed in a vein).

the exact dose is determined by the study protocol and is administered as a single injection.

after the injection you lie on a table while a pet scanner takes pictures of your heart to measure how the tracer is taken up by heart tissue or heart valves.

the whole imaging session usually lasts about one hour.

4 post‑scan observation

you remain in the facility for a short period while staff monitor you for any immediate reactions to the injection.

most people experience no side effects; if any symptoms occur, they are recorded.

5 follow‑up visit for safety check

within the next few days you have a brief telephone or clinic visit to report any delayed side effects.

the study team records any adverse events that may be related to the tracer.

6 additional scan for cardiac sarcoidosis patients

if you have suspected cardiac sarcoidosis, your doctor may start immunosuppressive therapy as part of standard care.

after a predefined period (for example three months), you return for a second pet scan using the same al[18f]f-nota-folate injection.

the second scan allows comparison of tracer uptake before and after therapy.

7 final study completion

after the required imaging and safety visits are finished, the study participation ends.

your data are kept confidential and used to evaluate the diagnostic value of the tracer.

Who Can Join the Study?

Be at least 18 years old and have a doctor’s suspicion of cardiac sarcoidosis, a condition that may affect the heart muscle, and need further testing with a heart MRI (magnetic resonance imaging) or a special scan called [18F]FDG PET.
Be at least 18 years old and have a doctor’s suspicion of infective endocarditis, an infection of a natural or artificial heart valve, that requires additional diagnostic testing.
If you are a healthy volunteer, be 50 years or older, be a woman who is post‑menopausal (no longer having periods), and have no history of heart disease, ongoing inflammatory disease, cancer, or active infection.
Be able to sign a written consent form agreeing to take part in the study.

Who Cannot Join the Study?

Being pregnant or breastfeeding (nursing a baby).
Having a known hypersensitivity (allergy) to medicines that contain folate‑based compounds (a type of vitamin) or to the inactive ingredients (excipients) in the study drug.
For women of childbearing potential (women who could become pregnant): you must be willing and able to use a reliable method of contraception (birth control) during the study and for 24 hours after the last dose, and you must have a negative pregnancy test (urine or blood test) within 24 hours before each dose.
Having a clinically unstable condition that the doctor believes would make the imaging unsafe or not possible.
Taking systemic immunosuppressive therapy (medicines that suppress the whole immune system) for more than 7 days before the first imaging scan.
Being unable to complete the study procedures as required by the study plan.
Having severe renal dysfunction (very poor kidney function) defined as a kidney filtration rate (CKD‑EPI GFR) less than 20 ml/min/1.73 m².
Receiving intravenous antibiotic therapy (antibiotics given through a vein) for more than 14 days.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Turku University Hospital	Turku	Finland
Siopowqhdsaz	Pori	Finland
Hdrbfmyt Uligrxlpzo Csnnstr Hgnleukh	Helsinki	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.10.2026

Trial locations

Al[18F]F-NOTA-folate is a special imaging agent that is given to patients through an intravenous injection. It contains a tiny amount of a radioactive material that can be seen on a PET scan. Once injected, it travels through the bloodstream and attaches to certain cells in the heart. By measuring how much of this agent is taken up by the heart muscle or heart valves, doctors can see patterns that help them decide if a patient might have cardiac sarcoidosis or an infection of the heart valves (infective endocarditis). This test does not treat the disease; it simply provides detailed pictures that aid in making a correct diagnosis.

Investigated Diseases:

Cardiac sarcoidosis

Infective endocarditis – An infection of the inner lining of the heart chambers and valves, usually caused by bacteria that enter the bloodstream. It leads to inflammation and damage of valve tissue, often resulting in clumps of bacteria and cellular debris on the valves. These clumps can enlarge and affect heart function over time.

Cardiac sarcoidosis – An inflammatory condition where small clusters of immune cells form granulomas in the heart muscle. The granulomas may disrupt the heart’s electrical system and impair muscle contraction. Over months or years the disease can cause thickening or scarring of heart tissue, altering how the heart works.

Trial ID:

2026-526655-59-00

Trial Phase:

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

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Diagnostic PET Study of Al[18F]F-NOTA-folate in Patients with Suspected Cardiac Sarcoidosis or Infective Endocarditis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?