Study on Gallium Citrate Ga-68 PET/CT for Diagnosing Prosthetic Valve Infective Endocarditis in Patients Suspected of Having the Condition

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What is this study about?

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.

1 joining the study

Eligibility is confirmed based on criteria such as being an adult over 18 years old, having a prosthetic heart valve, and being suspected of having infective endocarditis. Consent is required.

2 initial assessment

An initial assessment is conducted to gather clinical, microbiological, and imaging data. This information is discussed in a multidisciplinary meeting focused on endocarditis.

3 administration of medication

The medication 68 Gallium citrate is administered as a solution for injection. This is used for the PET/CT scan to help diagnose prosthetic valve infective endocarditis.

4 PET/CT scan

A PET/CT scan is performed using the injected 68 Gallium citrate. This scan helps in diagnosing prosthetic valve infective endocarditis by estimating the sensitivity of the imaging technique.

5 evaluation of results

The results of the PET/CT scan are evaluated for sensitivity, specificity, and predictive values. The inter-observer reproducibility is also assessed.

6 comparison with other imaging

The results from the 68Ga-PET/CT are compared with those from 18FDG-PET/CT to evaluate discrepancies in infection spread and pathogen entry.

7 completion of participation

Participation in the study concludes after all assessments and evaluations are completed. The estimated end date for the trial is June 30, 2026.

Who Can Join the Study?

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

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.07.2024

Trial locations

Investigated drugs:

Gallium Citrate Ga-68

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.

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.

Trial ID:

2024-514331-24-00

Protocol code:

CHUBX 2020/49

NCT ID:

NCT05446376

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Gallium Citrate Ga-68 PET/CT for Diagnosing Prosthetic Valve Infective Endocarditis in Patients Suspected of Having the Condition

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