Using Gallium 68 PET/CT to diagnose infective endocarditis in patients with prosthetic valves
Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
This study is testing if a new type of imaging called Gallium 68 PET/CT can better diagnose heart infections in people with artificial heart valves compared to the current standard method.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05446376 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to evaluate the effectiveness of Gallium 68 Positron Emission Tomography (PET) combined with Computed Tomography (CT) in diagnosing infective endocarditis in patients with prosthetic heart valves. The study compares the diagnostic performance of 68Ga-PET/CT against established criteria from the European Society of Cardiology (ESC) 2023, following a three-month follow-up period. The goal is to reduce false negatives associated with the current standard, 18F-fluorodeoxyglucose (18FDG) PET/CT, particularly in patients who may struggle with dietary restrictions required for the latter. A panel of experts will confirm the final diagnosis based on clinical, microbiological, and imaging data.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a prosthetic heart valve who are suspected of having infective endocarditis.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to PET/CT will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of infective endocarditis, improving patient outcomes and treatment strategies.
How similar studies have performed: While 18FDG-PET/CT has shown significant sensitivity, the use of Gallium 68 PET/CT is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Carine GREIB, MD — University Hospital, Bordeaux
- Study coordinator: Carine GREIB, MD
- Email: carine.greib@chu-bordeaux.fr
- Phone: (0)5 57 65 64 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.