About this trial
CiGal-EI-TEP is an exploratory study that aim to assess the diagnostic performance of 68Ga Positron emission tomography (PET) / Computed Tomography (CT) for the diagnosis of prosthetic valve infective endocarditis in comparison with the final diagnosis established according to the ESC 2023 criteria, after 3 months of follow-up, by a panel of experts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patient (over 18 years old);
patient with a prosthetic heart valve;
patient suspected of infective endocarditis (on clinical and/or microbiological and/or imaging data);
patient whose history is discussed in the multidisciplinary meeting dedicated to endocarditis;
Disqualifiers
pregnant or breastfeeding women;
women of childbearing potential not using effective contraception;
patients referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent);
subject in a period of relative exclusion due to another protocol;
Trial design
Single group
Treatments tested in this trial
68Ga-citrate PET/CT
DrugPET/CT Imaging with 68Ga-citrate PET/CT injection
Treatment groups
Trial outcomes
Primary outcomes
Sensitivity of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve
The final diagnosis of infective endocarditis is established according to the ESC 2023 criteria (assessed at 3 months by a panel of experts).
Secondary outcomes
Diagnostic accuracy of 68Ga citrate PET / CT scan CT for prosthetic valve infective endocarditis in patients suspected of infective endocarditis on prosthetic valve
Specificity, positive and negative predictive values of 68Ga-PET/CT for the diagnosis of infective endocarditis on prosthetic valve in patients suspected of infective endocarditis on prosthetic valve.
Inter-observer reproducibility of 68Ga-citrate PET/CT interpretation
Intraclass correlation coefficient and/or Cohen's Kappa.
Comparison of diagnostic accuracy of 68Ga-PET/CT and 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve.
Sensitivity, specificity and positive and negative predictive values of 18FDG-PET/CT for the diagnosis of infective endocarditis on prosthetic valve.
o Agreement between 68Ga-PET/CT and 18FDG-PET/CT for the evaluation of the spread of infection assessment and the search for the initial portal of pathogen entry
Cohen's Kappa
Sponsors and contacts
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