Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 1 step.

  1. Step 1

    Imaging procedure

    An intravenous injection, which means a liquid is delivered directly into a vein, is administered. this injection contains fludesoxiglucosa (18f) at a dose of 5 mbq/kg (megabecquerels per kilogram of body weight).

    This substance is used for a pet/ct scan, a type of imaging that helps to visualize biological processes in the body.

Who can join the trial?

7 criteria

  • 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 trial?

5 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Fludeoxyglucose (18F) - This substance is given as an injection directly into a vein to be used as a specialized imaging tool in medical scans. It is widely used in hospitals to help doctors see how well different tissues and organs are functioning. The medication works by acting like a sugar molecule that carries a tiny amount of radioactive energy, allowing it to be tracked by a scanner as it is absorbed by cells with high energy needs. It is classified as a radiopharmaceutical used primarily for diagnostic imaging.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524624-21-00Protocol codePREDICT studyEstimated enrolment200 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.