PET/MR Imaging In Patients With Infective Endocarditis

PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Infective endocarditis (infection of the heart valves or lining of the heart) and device infection (where a pacemaker device or wire becomes infected) are of particular interest in this area.

The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. PET scanning combined with CT scanning will be used instead for patients who aren't able to undergo MRI scanning. This will allow abnormal areas within the heart in these conditions to be characterised, alongside treatment regimens, in a way which hasn't been done before.

All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time, passed out of the body in urine. Patients with infective endocarditis involving their own heart valve will undergo an MRI scan as part of the PET scan. Patients with infective endocarditis involving a metal or prosthetic heart valve and also patients who have pacemaker infections, instead of an MRI, will have a CT scan. The reason for this is that CT is better for looking at metal and prosthetic heart valves and patients with pacemakers can't have MRI scans because the strong magnet in the scanner can affect the pacemaker. The scan will be performed twice; once before treatment and once after treatment has been established.

If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen's Medical Research Institute

Edinburgh, Midlothian, EH16 4TJ, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age criteria as follows:

Native valve endocarditis >30 years
Prosthetic valve endocarditis/device infection >50 years
Non-infective post-operative patients >65 years

Additional inclusion criteria:

Completion of informed consent
Established diagnosis of one of the conditions listed below:

I. Native valve infective endocarditis; established diagnosis by Dukes criteria II. Prosthetic valve or device-related infection; established diagnosis by Dukes criteria (in the case of valves), or by microbiological, haematological and biochemical grounds (in the case of device-related infection) III. Recent implant of prosthetic valve and/or cardiac device

Exclusion criteria

Inability or unwilling to give informed consent
Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial
Major intercurrent illness with life-expectancy <2 years
Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)
Adverse reaction or hypersensitivity to 18F-FDG PET tracer
NYHA Class IV heart failure
Insulin-dependent diabetes mellitus
Patients with atrial fibrillation and poor rate control
Contraindications to MR for patients in the groups undergoing PET/MR including any patient with suspected metal in their eyes
Previous history of contrast allergy of adverse reactions (iodinated contrast in patients undergoing PET/CT and gadolinium in patients undergoing PET/MR)

Treatment and study plan

18F-FDG

Other

Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.

Primary outcomes

Myocardial 18F-FDG uptake

Time frame: 1 year

Quantification of myocardial PET tracer uptake, early and late time-points

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Registry information

Official study title

Molecular Imaging in Infective Endocarditis Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR) and Computed Tomography (PET/CT)

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Aug 13, 2018
Registry last updated: Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed