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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Jul 1, 2022

Keywords

ClinConnect Summary

This clinical trial, called CiGal-EI-TEP, is investigating a new imaging technique using a special substance called Gallium 68 Citrate (68Ga) to help diagnose a serious heart infection known as prosthetic valve infective endocarditis. This infection can occur in patients who have artificial heart valves. The study will compare the results of this new imaging method with the final diagnosis made by a team of experts after following patients for three months. The goal is to see if 68Ga-PET/CT can accurately help detect this infection.

To participate in this trial, you must be an adult over 18 years old with a prosthetic heart valve and show signs of infective endocarditis based on clinical tests or imaging. You’ll also need to be part of a discussion among specialists who focus on heart infections. If you decide to join, you will receive the imaging test and be monitored closely. It's important to know that pregnant or breastfeeding women, as well as certain other individuals, are not eligible to participate. The findings from this study could lead to better ways to diagnose this serious condition in the future.

Gender

ALL

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;
• • 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).