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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

CiGal-EI-TEP is an exploratory study that aim to assess the diagnostic performance of 68Ga-PET/CT for the diagnosis of prosthetic valve infective endocarditis in comparison with the final diagnosis established according to the ESC 2015 criteria, after 3 months of follow-up, by a panel of experts.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux

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;

• 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).