18-FDG PET/CT Imaging and Clinical Decisions in Infective Endocarditis

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To evaluate the impact of 18-FDG PET/CT on the Duke-Li criteria for IE diagnosis To evaluate the performance of 18-FDG PET/CT in detecting valve damages and extracardiac complications induced by the IE To evaluate whether 18-FDG PET/CT may help identify the infection's portal of entry To evaluate whether the detection of extracardiac complications by FDG PET/CT is associated with the 6-months survival rate To identify clinical and biological determinants of extracardiac IE localizations and prognosis To determine the inter-reader interpretation of the18-FDG PET/CT results and the reproducibility in preparation and acquisition method

Official Title
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Effect of 18-FDG PET/CT Imaging on Clinical Decision Making During the Acute Phase of Infective Endocarditis: a Multicenter Prospective Impact Study

Conditions
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Infective Endocarditis

Intervention / Treatment
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* Procedure: 18-FDG PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged ≥ 18 years Presenting IE Duke-Li definite - Duke-Li possible or strong suspicion of IE Duke-Li not definite or possible, with initiation of IE antibiotic therapy. Transthoracic or transesophageal ultrasound performed. A stable clinical condition which does not require immediate surgery or contraindicate patient mobilization Absence of cardiac surgery for the current IE episode Covered by the French health insurance system Having given and signed the written study informed consent to the study. Exclusion Criteria: Patient having already had a 18-FDG PET/CT in the current episode Contraindication to perform a 18-FDG PET/CT Early prosthetic valve IE (cardiac surgery within last 2 months) Inability to understand the information form Pregnant or lactating woman. Cardiac surgery between inclusion and 18-FDG PET/CT Participation to any clinical trial including 18-FDG PET/CT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18-FDG PET/CT scan<br>All patients will undergo a whole body PET/CT scan | Procedure: 18-FDG PET/CT scan<br>* Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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…) | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 6 months | 
| 6-month mortality rate | number of dead patients 6 months after inclusion | 6 months | 
| Determinants of change in therapeutic plan as defined in primary outcome | Clinical and biological determinants of therapeutic changes | 6 months | 
| 18-FDG PET/CT inter-reader reproducibility | questionnaire | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infective endocarditis, 18-FDG PET/CT, Impact, Patient's management, Diagnostic