NCT05446376 Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
| NCT ID | NCT05446376 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Bordeaux |
| Condition | Infective Endocarditis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-11-22 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-11-22 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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).
Contact & Investigator
Carine GREIB, MD
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT05446376 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infective Endocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05446376 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05446376 currently recruiting?
Yes, NCT05446376 is actively recruiting participants. Contact the research team at carine.greib@chu-bordeaux.fr for enrollment information.
Where is the NCT05446376 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT05446376 clinical trial?
NCT05446376 is sponsored by University Hospital, Bordeaux. The principal investigator is Carine GREIB, MD at University Hospital, Bordeaux. The trial plans to enroll 40 participants.