Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 68Ga-citrate PET/CT

    Drug

    PET/CT Imaging with 68Ga-citrate PET/CT injection

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: 68Ga-citrate PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
3 months after baseline (Day 0)

Secondary outcomes

1

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.

Time frame
3 months after baseline (Day 0)
2

Inter-observer reproducibility of 68Ga-citrate PET/CT interpretation

Intraclass correlation coefficient and/or Cohen's Kappa.

Time frame
3 months after baseline (Day 0)
3

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.

Time frame
3 months after baseline (Day 0)
4

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

Time frame
3 months after baseline (Day 0)

Other outcomes

Sponsors and contacts

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