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New treatment option for Infective Endocarditis
Official title Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis
ClinicalTrials.gov ID: NCT05446376
What this study is testing
What is 68Ga-citrate PET/CT?
68Ga-citrate PET/CT is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for infective endocarditis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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...
- 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).
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.