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

NCT05146180 | Recruiting

• 1 other identifier: CHB18.10
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Endocarditis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between parametric positron emission computed tomography and scintigraphy with labelled leukocytes

  3 months

Study Arms (1)

Parametric positron emission computed tomography

EXPERIMENTAL

Device: Parametric positron emission computed tomography

Interventions

Parametric positron emission computed tomography DEVICE

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

Parametric positron emission computed tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

RECRUITING

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mathieu Chastan, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathieu Chastan, MD

CONTACT

+33276673032; mathieu.chastan@chb.unicancer.fr

Doriane Richard, PhD

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 6, 2021
• Study Start: February 24, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)