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

CHUBX 2020/49

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.

2024-02-01

2026-02-01

2026-02-01

Not yet recruiting

Early phase I

40

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-01-12