FDG-PET changes after finishing antibiotics for prosthetic valve endocarditis
Evolution of Positron Emission Computed Tomography (PET) Fixation With Fluorodeoxyglucose (FDG) at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
This test tries to see if an FDG-PET scan done at the end of antibiotic treatment can find people with prosthetic valve endocarditis who still have infection and are more likely to relapse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, France) |
| Trial ID | NCT05989152 on ClinicalTrials.gov |
What this trial studies
This is a single-center prospective cohort of 50 adults with definite prosthetic valve endocarditis who had pathological valvular FDG uptake on an initial PET done early in treatment and were not operated in the acute phase. Each participant will receive an FDG-PET at the end of curative antibiotic therapy to determine whether valvular or extracardiac pathological uptake persists. The study will compare quantitative PET uptake before and after treatment, estimate the proportion with persistent valvular uptake, and record relapse at 6 months. An automated artificial-intelligence analysis of PET changes will also be tested for its ability to predict relapse.
Who should consider this trial
Good fit: Adults (18+) with definite prosthetic valve endocarditis who had pathological FDG uptake on an initial PET performed within 15 days of starting antibiotics and who were not operated during the acute episode.
Not a fit: Patients who had valve replacement in the acute phase, who had no pathological FDG uptake on the initial PET, who cannot undergo PET/CT, or who meet exclusion criteria (eg, pregnancy) are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this could help identify patients who need additional surgery or longer antibiotics and spare others from unnecessary treatment or intensive follow-up.
How similar studies have performed: FDG-PET is established for diagnosing prosthetic valve endocarditis and finding extracardiac foci, but using end-of-treatment PET to predict relapse is relatively limited and remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
"Inclusion criteria: * Patient aged 18 or over; * Have a prosthetic valve implanted surgically or by catheter for at least 3 months; * Presenting a definite IE on a prosthetic valve (ESC definition in force); * Having benefited from an FDG-PET examination for diagnostic purposes as part of the treatment revealing pathological hyperuptake at the level of the prosthetic valve AND carried out \<15 days after the start of antibiotic therapy for infective endocarditis; * Absence of cardiac surgical intervention performed for the current episode of AE or planned before the end-of-treatment FDG-PET Exclusion criteria: * Patient under legal protection, guardianship or curators; * Pregnancy, breastfeeding; * Patient not affiliated to a health insurance scheme or not a beneficiary of a social security scheme; * Simultaneous participation in a study on FDG-PET; * Absence of informed consent signed by the patient."
Where this trial is running
Paris, France
- Hôpital Bichat-Claude Bernard — Paris, France, France (Recruiting)
Study contacts
- Principal investigator: François Rouzet, MD, PHD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: François Rouzet, MD, PHD
- Email: francois.rouzet@aphp.fr
- Phone: 01.40.25.64.11
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.