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

Centre Henri Becquerel

Status: Enrolling

Conditions: Endocarditis

Treatments: Device: Parametric positron emission computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT05146180

CHB18.10

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Parametric positron emission computed tomography

Experimental group

Treatment:

Device: Parametric positron emission computed tomography