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

Not Applicable

Recruiting

• Conditions: Endocarditis
• Interventions: Device: Parametric positron emission computed tomography

• Registration Number: NCT05146180
• Lead Sponsor: Centre Henri Becquerel

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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-12-06
• Study Start: 2022-02-24
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parametric positron emission computed tomography	Parametric positron emission computed tomography	-

Primary Outcome Measures

Name	Time	Method
Determination of diagnostic value of parametric positron emission computed tomography	3 months	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

Secondary Outcome Measures

Name	Time	Method
Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes	3 months	comparison between diagnosis established by parametric positron emission computed tomography and scintigraphy with labelled leukocytes

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France