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

Endocarditis Clinical Trial

— PARAVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146180
• Other study ID #: CHB18.10
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2022
• Source: Centre Henri Becquerel
• Contact: Mathieu Chastan, MD
• Phone: +33276673032
• Email: mathieu.chastan[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocarditis

Intervention

Device:
• Parametric positron emission computed tomography
Patients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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