Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
Recruiting
Phase 2Interventional Study
Infective Endocarditis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
40 (estimated)
Sponsor
University Hospital, Bordeaux · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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;
…
Inclusion Criteria:
* 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;
* patient beneficiary of a social security scheme;
* free, informed and written consent signed by the participant and the investigator.
Exclusion Criteria:
* 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;
* known contraindication to PET/CT with injection of radiotracers (hypersensitivity to radiopharmaceuticals and/or excipients).
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