Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis

Study Overview
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Brief Summary
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The objective of this study is to determine if early parametric positron emission computed tomography is useful to diagnose cardiac prosthetic valve infections.

Detailed Description
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In addition to routine examinations (biological and microbiological tests, transesophageal or transthoracic ultrasound, transesophageal or transthoracic ultrasound, and leukocyte scintigraphy) of a parametric acquisition during the positron emission computed tomography parametric acquisition during positron emission computed tomography , this examination being itself planned in a standard way. The definitive diagnosis according to the Duke-Li criteria will be established three months later in a multidisciplinary consultation meeting. The final diagnosis according to the Duke-Li criteria will be made three months later in a multidisciplinary consultation meeting, blinded to the results of the parametric positron emission computed tomography, and with knowledge of the results of the standard positron emission computed tomography and the entire work-up. Results and all the complementary work-up.

Official Title
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Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study

Conditions
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Endocarditis

Intervention / Treatment
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* Device: Parametric positron emission computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age superior to18 years, Effective contraception for women of childbearing age or negative pregnancy test on the day of the exam Good general condition. WHO ≤ 1 Suspicion of endocarditis on a prosthetic heart valve implanted more than 3 months ago Labeled polynuclear scintigraphy performed within a maximum of 15 days before positron emission computed tomography Standard positron emission computed tomography planned as part of the extension assessment Informed and signed consent before any specific study procedure. Patient affiliated to the social security system Exclusion Criteria: Presence of an active cancer in the previous three years Pregnancy or breastfeeding Poorly controlled diabetic patients Protected adults (under guardians or curators) Impossible decubitus (orthopnea, ...), Hypersensitivity to FDG or to one of the excipients of the radiopharmaceutical.

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: Parametric positron emission computed tomography<br> | Device: Parametric positron emission computed tomography<br>* Patients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of diagnostic value of parametric positron emission computed tomography | area under the curve of the Ki parameter (and the Vd parameter) as a function of the presence of endocarditis diagnosed during the multidisciplinary consultation meeting at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes | comparison between diagnosis established by parametric positron emission computed tomography and scintigraphy with labelled leukocytes | 3 months |