Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Not recruitingProsthetic valve endocarditis
Study on Gallium Citrate Ga-68 PET/CT for Diagnosing Prosthetic Valve Infective Endocarditis in Patients Suspected of Having the Condition
Verified siteInvestigational
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a heart condition known as prosthetic valve infective endocarditis. This condition occurs when an infection affects an artificial heart valve. The study will use a special imaging technique called PET/CT with a substance known as Gallium 68 citrate. This substance is injected into the body and helps doctors see detailed images of the heart and detect infections more accurately.
The purpose of the study is to determine how effective the 68Ga-PET/CT scan is in diagnosing infections in patients who have artificial heart valves and are suspected of having this type of infection. The study will compare the results of the 68Ga-PET/CT scan with another imaging method called 18FDG-PET/CT to see which one provides better information about the infection.
Participants in the study will undergo the 68Ga-PET/CT scan, and the results will be analyzed to see how well this method can identify the infection. The study will also look at how consistent the results are when different doctors review the scans. This research aims to improve the diagnosis and treatment of infections in patients with artificial heart valves.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Adult patient (over 18 years old)
- Patient with a prosthetic heart valve, which is an artificial valve placed in the heart
- Patient suspected of having **infective endocarditis**, which is an infection of the inner lining of the heart, based on clinical signs, lab tests, or imaging results
- Patient whose medical history is reviewed in a meeting with various healthcare specialists focused on endocarditis
- Patient who is part of a social security program
- Patient who has given free, informed, and written consent, meaning they understand the study and agree to participate
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Investigated drugs
Gallium 68 citrate (68Ga-PET/CT) is a special imaging agent used in PET/CT scans. In this clinical trial, it helps doctors see if there is an infection in a heart valve that has been replaced with an artificial one. The scan can show areas of infection by highlighting them, which helps in diagnosing the condition more accurately.
What is already known about the treatment
Gallium 68 Citrate – This medication is administered through an intravenous injection and is used in conjunction with PET/CT imaging. It is currently being studied in clinical trials for its effectiveness in diagnosing prosthetic valve infective endocarditis. The main therapeutic indication is to assist in the detection of infections in patients with prosthetic heart valves. At the molecular level, Gallium 68 binds to areas of inflammation and infection, allowing for enhanced imaging of these sites. It is classified as a radiopharmaceutical agent used in diagnostic imaging.
Investigated diseases
Prosthetic Valve Infective Endocarditis – This disease occurs when an infection affects the inner lining of the heart, specifically on or around a prosthetic heart valve. It is typically caused by bacteria entering the bloodstream and attaching to the valve. The condition can lead to inflammation and damage to the heart valve, potentially affecting its function. Symptoms may include fever, heart murmurs, and signs of heart failure. The progression of the disease can vary, with some cases developing rapidly while others progress more slowly. It is important to monitor for complications that can arise from the infection spreading to other parts of the body.
Ongoing clinical trials in Prosthetic valve endocarditis
Other trials in this disease – keep exploring while you decide
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Endocarditis
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Study of Switching from Intravenous to Oral Antibiotics in Patients with Infective Endocarditis Using a Drug Combination
Registered drug
- Disease:Endocarditis
- Substances:AmoxicillinCefazolin Sodium+12
Countries:
Belgium
Belgium- Participants:18–64 years · 65+ years
- Substances:Amoxicillin
- Sponsor:UZ Leuven
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Endocarditis
RecruitingRegistered drug
Study on Shortened Antibiotic Treatment for Infectious Endocarditis Using Vancomycin, Meropenem, and Ceftriaxone for Patients with Left-Sided Heart Infection
Registered drug
- Disease:Endocarditis
- Substances:AmpicillinCefotaxime+6
Countries:
Sweden
Sweden- Participants:18–64 years · 65+ years
- Substances:Ampicillin
- Sponsor:Region Skane
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514331-24-00Protocol codeCHUBX 2020/49Estimated enrolment40 patientsSponsorCentre Hospitalier Universitaire De Bordeaux
sourced from the EU Clinical Trials Register and site verification
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