Using fludeoxyglucose (18F) in PET/CT imaging to diagnose and monitor cardiovascular device infections

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What is this study about?

This study focuses on Cardiovascular device infections, which are infections that occur in medical devices placed in the heart or blood vessels, such as pacemakers or artificial valves. The purpose of the study is to determine if a specialized way of looking at medical images can better identify these infections. To do this, an imaging technique called PET/CT, which uses a computed tomography scan combined with a specialized camera, will be used. This process involves an intravenous injection of a radioactive substance called fludeoxyglucose (18F), a type of sugar marked with a tracer that allows doctors to see how cells are using energy in the body.

During the study, radiomics will be applied to the images. This is a method that uses computers to extract large amounts of detailed data from medical scans that are not visible to the human eye. These computer-generated details are then analyzed to help distinguish between an actual infection and other types of inflammation. This approach may help in predicting whether an infection is healing, which could eventually help in deciding when it is safe to stop using long-term antimicrobial therapy, which is medication used to fight bacteria.

Who Can Join the Study?

You must be at least 18 years old.
You must have an implanted cardiovascular device, which is a medical tool placed inside your heart or blood vessels, such as an artificial heart valve, a device to help the heart pump, or a tube used to repair blood vessels.
If you are part of the group with infections, you must have a confirmed cardiovascular device infection (an infection involving your implanted device) based on a thorough review by a team of medical experts.
If you are part of the control group, you must have no signs or suspicion of an infection at the time you join the study.
You must provide written informed consent, which means you have read all the information about the study and signed a document agreeing to participate.
Women who are able to become pregnant must have a negative pregnancy test using blood or urine before joining.
Women who can become pregnant must agree to use highly effective contraceptive methods, such as an intrauterine device (a small device placed in the uterus to prevent pregnancy) or having a partner who has had a vasectomy (a procedure for men that prevents pregnancy).

Who Cannot Join the Study?

You cannot participate if you have a reason why you cannot undergo an FDG-PET scan, which is a type of medical imaging that uses a special radioactive sugar to show how your body is functioning. This includes having allergies to the substances used or suffering from claustrophobia, which is an intense fear of being in small, enclosed spaces.
You cannot take part if you are pregnant or currently breastfeeding.
You cannot join the study if your clinical data, which are the written records of your health and medical history, are missing or incomplete, or if your medical imaging studies, such as X-rays or scans, are not available for review.
You cannot participate if you choose not to give informed consent, which is the formal agreement to take part in a study after being fully told about all its details and risks, or if you decide to leave the study later.
You cannot participate if the FDG-PET studies do not meet the necessary quality standards, meaning the images produced are not clear or accurate enough to be used for the research.

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	Status
Hospital Clinic De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	30.04.2026

Trial locations

Investigated drugs:

Fludeoxyglucose (18F)

Fludeoxyglucose (18F) is a special radioactive liquid that is injected into a vein. It is used during a PET scan to help doctors see how much sugar is being used by tissues in the body, which can help them identify areas of infection or inflammation related to medical devices.

Investigated diseases:

Device related infection

Cardiovascular device infection – This condition occurs when germs like bacteria or fungi grow on medical devices placed inside the heart or blood vessels. These devices can include pacemakers, defibrillators, or artificial heart valves. The infection typically begins when microorganisms attach to the surface of the device or the surrounding tissue. As the infection progresses, it can form a layer of germs and debris known as a biofilm. This biofilm protects the microorganisms and allows the infection to persist on the hardware. The presence of the infection can lead to inflammation in the areas immediately surrounding the implanted device.

Trial ID:

2025-524624-21-00

Protocol code:

PREDICT study

Trial Phase:

Therapeutic confirmatory (Phase III)

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