Actively Recruiting
Evolution of Positron Emission Computed Tomography (PET) Fixation With Fluorodeoxyglucose (FDG) at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-05
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with prosthetic valve endocarditis (PVE) who have shown abnormal FDG uptake on initial FDG-PET scans and were not referred for valve replacement surgery during the acute phase. This study aims to determine if FDG-PET can identify those at higher risk of PVE relapse after antibiotic treatment. The goal is to improve patient management by identifying persistent infection or cure, which could guide decisions on surgery, suppressive antibiotic therapy, or follow-up strategies. The study involves a single-center prospective cohort of 50 adults with definite PVE based on ESC 2015 criteria. Participants have pathological FDG uptake on the prosthetic valve at the start of antibiotic treatment and are medically treated without acute phase surgery. FDG-PET scans are performed at the end of antibiotic treatment to assess changes in valvular and extracardiac FDG uptake. The study also evaluates artificial intelligence analysis to predict relapse risk. Participants will undergo FDG-PET imaging before and after curative antibiotic treatment. Researchers will measure valvular and extracardiac FDG uptake intensity and monitor for PVE relapse within six months. The study will assess the impact of end-of-treatment PET-FDG findings on antibiotic therapy decisions. Follow-up includes clinical monitoring for relapse, with data collected on antibiotic treatment duration and diagnostic accuracy of AI prediction methods.
CONDITIONS
Brief Title
Evolution of PET Fixation With FDG at the End of Antibiotic Treatment of Infective Endocarditis on Valvular Prosthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 or over
- Have a prosthetic valve implanted surgically or by catheter for at least 3 months
- Presenting a definite infective endocarditis on a prosthetic valve according to ESC definition
- Having undergone an FDG-PET exam showing pathological hyperuptake on the prosthetic valve within 15 days after starting antibiotic therapy
- No cardiac surgery performed or planned before the end-of-treatment FDG-PET
You will not qualify if you...
- Patient under legal protection, guardianship, or curatorship
- Pregnancy or breastfeeding
- Not affiliated with a health insurance or social security scheme
- Simultaneous participation in another FDG-PET study
- Absence of signed informed consent by the patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of antibiotic treatment as prescribed
Participants undergo curative antibiotic treatment for prosthetic valve infective endocarditis.
Visits occur as part of routine care; specific visit schedule not defined in the trial
Duration - Within 15 days after completing antibiotic treatment
Participants undergo an FDG-PET scan at the end of antibiotic treatment to assess valvular and extracardiac FDG uptake.
1 visit (in-person) for FDG-PET scan
Duration - 6 months
Participants are monitored for up to 6 months after treatment to evaluate for relapse of endocarditis and therapeutic outcomes.
Follow-up visits as per clinical practice; specific schedule not defined in the trial
Trial Site Locations
Total: 1 location
1
Hôpital Bichat-Claude Bernard
Paris, France, France, 75018
Actively Recruiting
Research Team
F
François Rouzet, MD, PHD
X
Xavier Duval, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here