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

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

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

Study Overview

• Status: Recruiting
• Conditions: Endocarditis
• Intervention / Treatment: Device: Parametric positron emission computed tomography

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathieu Chastan, MD; Phone Number: +33276673032; Email: mathieu.chastan@chb.unicancer.fr

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • Centre Henri Becquerel
    • Contact: Mathieu Chastan, MD; Email: mathieu.chastan@chb.unicancer.fr
    • Contact: Doriane Richard, PhD; Email: doriane.richard@chb.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parametric positron emission computed tomography	Device: Parametric positron emission computed tomography; Patients will undergo parametric positron emission computed tomography in 15 days after the labeled polynuclear scintigraphy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Mathieu Chastan, MD, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Endocarditis
• Other Study ID Numbers: CHB18.10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No