An interventional study of 18-FDG PET/CT scan in Infective Endocarditis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
The purpose of this study is to assess the impact of 18-FDG positron emission tomography (PET)/computed tomography (CT) imaging in the management of patients with suspected or proven IE in detecting cardiac valve damages and other extracardiac complications. The study will evaluate whether this procedure can change the clinical decisions (treatments, valve surgery, patients' overall care) and modify the diagnosis of IE.
Introduction:
Infective endocarditis (IE) is a rare disease, often difficult to diagnose with a high mortality rate. Extra-cardiac manifestations, which can occur in 30 to 80% of cases, impact the outcome of the disease. Identifying these manifestations may help confirm an uncertain diagnosis and optimize patients' management.
18-FDG PET/CT imaging, widely used for cancer staging, may also detect hyper-metabolic areas related to extracardiac infectious complications of IE. It provides the opportunity to detect all extracardiac IE infectious complications through a single examination. The impact of 18-FDG PET/CT imaging on the management of IE has yet to be completely evaluated.
Hypothesis:
18-FDG PET/CT implementation could result in both shortening of the initial diagnostic work-up of IE and therapeutic optimization.
Primary objective:
To evaluate the impact of 18-FDG PET/CT on patients' management, as measured by changes in IE therapeutic plans.
Secondary objectives:
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's enrollment of 150 is above the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will undergo a whole body PET/CT scan
Procedure: 18-FDG PET/CT scan
Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis
Proportion of patients with a change in IE therapeutic plan
at least one modification in antimicrobial or anticoagulant therapy (types, route, dose, number, duration, indication…) or any modification of surgery (type, timing, indications…)
Time frame: 7 days
Proportion of patients with Duke-Li classification modifications
Proportion of patients with change in diagnostic classification of IE (definite, possible, excluded) according to the Duke-Li classification
Time frame: 6 months
Performances of 18-FDG PET/CT in detection of IE localization as compared to other usual procedures
1/ in detecting valve damages and extracardiac complications and 2/ in identify the portal of entry of IE
Time frame: 6 months
6-month mortality rate
number of dead patients 6 months after inclusion
Time frame: 6 months
Determinants of change in therapeutic plan as defined in primary outcome
Clinical and biological determinants of therapeutic changes
Time frame: 6 months
18-FDG PET/CT inter-reader reproducibility
questionnaire
Time frame: 6 months
Plan to share: Undecided
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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