Parametric PET imaging for infections on prosthetic heart valves
Interest of Parametric Positron Emission Computed Tomography Imaging in the Diagnosis of Infections on Cardiac Valve Prosthesis : PARAVA Study
This study will test whether an advanced parametric PET scan helps diagnose infections in people with prosthetic heart valves.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Henri Becquerel Academic / other |
| Locations | 1 site (Rouen) |
| Trial ID | NCT05146180 on ClinicalTrials.gov |
What this trial studies
Adults with suspected prosthetic valve endocarditis will receive the usual diagnostic work-up (blood tests, echocardiography, labeled leukocyte scintigraphy) plus an added parametric FDG-PET/CT acquisition performed during their planned PET/CT. The parametric acquisition data are collected in addition to standard PET images and analyzed separately. A definitive diagnosis using the modified Duke-Li criteria will be established at a multidisciplinary meeting three months later, with reviewers blinded to the parametric PET results but aware of standard PET and other work-up. The study compares parametric PET findings to the final clinical diagnosis to see if the parametric approach improves early detection of prosthetic valve infections.
Who should consider this trial
Good fit: Adults (age >18) with suspected endocarditis on a prosthetic heart valve implanted more than three months earlier who can undergo FDG-PET/CT and provide informed consent.
Not a fit: People who are pregnant or breastfeeding, have had active cancer in the past three years, have poorly controlled diabetes, cannot lie flat for the scan, or are under legal protection are excluded and would not directly benefit from participation.
Why it matters
Potential benefit: If successful, this technique could enable earlier and more accurate diagnosis of prosthetic valve infections, allowing faster, targeted treatment.
How similar studies have performed: Standard FDG-PET/CT has demonstrated usefulness for prosthetic valve endocarditis, but parametric PET acquisition is a newer technique with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rouen
- Centre Henri Becquerel — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Mathieu Chastan, MD — Centre Henri Becquerel
- Study coordinator: Mathieu Chastan, MD
- Email: mathieu.chastan@chb.unicancer.fr
- Phone: +33276673032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.