AuthorisedTherapeutic use (Phase IV)Interventional

Application of radiomics in molecular imaging (18F-FDG-PET/CT) for diagnosis and follow-up of cardiovascular device infections: PREDICT study

The PREDICT study is investigating better ways to diagnose infections around heart devices, like pacemakers. It uses special scans called 18F-FDG-PET/CT. Researchers are testing if a new computer-based technique, called 'radiomics,' can find these infections more accurately than current methods. This involves special software analysing the images. They also want to see if this technology, combined with other patient information, can predict if an infection will clear up and if antibiotics can be stopped. Another goal is to understand how the tracing material used in the scan shows up in healthy people with heart devices, which helps distinguish between normal activity and infection.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Enrolment target

200

Start

07 Apr 2026

Cardiovascular device infections

What is this study about?

This study, called PREDICT, is looking into how we can improve the way doctors diagnose and follow up on infections that can sometimes happen around heart devices. These devices, like pacemakers or defibrillators, are very helpful for many people, but occasionally, an infection can develop near them. It's really important to find these infections quickly and make sure they are treated properly.

The main aim of this research is to see if a newer, more advanced way of looking at special scans, called 18F-FDG-PET/CT scans, is better at finding these infections. These scans use a small amount of a safe, mildly radioactive sugar, which helps highlight areas of infection or inflammation. The new technique, called 'radiomics,' uses powerful computer programs to analyse tiny details in these scans that human eyes might miss. This study compares radiomics to the usual way doctors look at these scans, to see which method is more accurate.

Beyond just finding infections, the study also wants to see if this advanced computer analysis can help predict how well an infection will respond to treatment. This could help doctors decide if a course of antibiotics is working or if it's safe to stop treatment. Researchers are also looking at how the scan appears in people with heart devices who don't have an infection. This helps them build a clearer picture of what a 'normal' scan looks like in these patients, making it easier to spot problems when they do arise.

Key takeaways

Exploring new computer methods to detect heart device infections earlier.
Comparing advanced scan analysis with standard doctor interpretation.
Aims to predict treatment success for these infections.
Helps understand normal scan appearances with heart devices.
Could lead to more accurate and quicker diagnoses for patients.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. You would be considered if you have a heart device and are being evaluated for a possible infection around it, or if you have a known infection that doctors are tracking.

The researchers are also interested in people who have permanent heart devices but do not have an infection, to help them understand what normal scans look like in these cases. This helps them to see the difference when an infection is present.

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.

Are you 18 years old or older?
Do you have a heart device (like a pacemaker or defibrillator)?
Are you being checked for a possible infection around your heart device?
Or do you have a known infection that doctors are monitoring?
Or do you have a heart device but no infection, and might be willing to help researchers understand normal scans?

Answer every question to see your result.

What does participation involve?

The information provided was brief, so details about participation are limited. If you take part, you would likely have one or more 18F-FDG-PET/CT scans, which involve receiving a small injection of a mildly radioactive sugar. You might also have blood tests and physical examinations as part of the normal care for your heart device and potential infection. How long you'd be involved isn't specified, but it would align with the usual monitoring and treatment time for heart device infections.

Potential risks and benefits

Potential benefits of participating include contributing to medical knowledge that could lead to better diagnosis and treatment of heart device infections for future patients. For you personally, the scans and assessments might help your doctors in managing your own condition. Potential risks associated with the 18F-FDG-PET/CT scan are generally low but include exposure to a small amount of radiation, similar to a few months of natural background radiation, and very rare allergic reactions to the tracing material. You would be fully informed of all procedures, and you have the right to withdraw from the study at any time without affecting your 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
Spain

Common questions

What is a heart device infection?

It's when germs get into the body and cause an infection around a device implanted near your heart, like a pacemaker or defibrillator.

What is a PET/CT scan?

It's a special type of scan that uses a tiny amount of a safe, radioactive sugar to create detailed pictures inside your body, helping doctors see areas of infection or inflammation.

What does 'radiomics' mean?

It's a new technique where powerful computers look at tiny details in your medical scans to find patterns that might otherwise be missed, helping doctors diagnose conditions.

Will taking part change my medical treatment?

This study aims to improve diagnosis, which could indirectly affect treatment in the future. However, your medical team will continue to make treatment decisions based on what's best for you.

Who is funding this research?

The information provided does not specify the funding source for this particular study.