Actively Recruiting
Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
Led by University Hospital, Bordeaux · Updated on 2026-02-03
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of PET/CT imaging with Gallium 68 citrate (68Ga-PET/CT) to diagnose prosthetic valve infective endocarditis, a challenging infection of heart valve replacements. This exploratory Phase 2 study compares the diagnostic accuracy of 68Ga-PET/CT with the standard 18F-fluorodeoxyglucose PET/CT (18FDG-PET/CT), based on final diagnoses determined by expert review after three months using the 2023 European Society of Cardiology criteria. The study aims to address limitations of 18FDG-PET/CT, especially in patients who find it difficult to follow dietary restrictions before the exam. Participants suspected of having infective endocarditis on prosthetic heart valves will undergo both imaging tests, with 68Ga-PET/CT performed either the day before, the same day, or the day after 18FDG-PET/CT. Both scans will be interpreted independently by experienced nuclear medicine physicians who are unaware of the final diagnosis. This allows a direct comparison of the two imaging methods' ability to detect infection. During the study, participants will be followed for three months to confirm the diagnosis through expert panel review using clinical, microbiological, and imaging data according to ESC 2023 guidelines. Researchers will measure the sensitivity of 68Ga-PET/CT for detecting prosthetic valve infection and compare its accuracy and agreement with the standard 18FDG-PET/CT. Safety and interpretation consistency between readers will also be monitored throughout the observation period.
CONDITIONS
Brief Title
Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (over 18 years old)
- Patient with a prosthetic heart valve
- Patient suspected of infective endocarditis based on clinical, microbiological, or imaging data
- Patient discussed in a multidisciplinary meeting dedicated to endocarditis
- Patient covered by a social security scheme
- Signed free, informed, and written consent by participant and investigator
You will not qualify if you...
- Pregnant or breastfeeding women
- Women of childbearing potential not using effective contraception
- Persons deprived of liberty by judicial or administrative decision, minors, adults under legal protection, or unable to consent
- Participants currently excluded due to involvement in another protocol
- Known allergy or contraindication to PET/CT radiotracers or their components
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 - 1 to 3 days
Participants undergo PET/CT imaging with both 68Ga-citrate PET/CT and 18FDG-PET/CT scans to evaluate for prosthetic valve infective endocarditis.
2 imaging visits (in-person) within 3 days
Duration - 3 months
Participants are followed for 3 months after imaging to confirm the diagnosis and monitor outcomes based on clinical and expert panel assessment.
Follow-up assessments as per clinical care; visit schedule may vary
Trial Site Locations
Total: 1 location
1
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
Research Team
C
Carine GREIB, MD
S
Sandrine FOUCHET
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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