Clinical trial NCT05146180: Interest of Parametric Positron Emission Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis
Official title: Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endocarditis
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determination of diagnostic value of parametric positron emission computed tomography
timeFrame: 3 months
Secondary outcomes:
measure: Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes
timeFrame: 3 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Mathieu Chastan, MD
role: PRINCIPAL_INVESTIGATOR
References: