Study of Gallium 68 PETCT Imaging for Diagnosing Infection in Patients With Prosthetic Heart Valves

What this Trial Is About

Researchers are evaluating the use of PETCT imaging with Gallium 68 citrate 68Ga-PETCT to diagnose prosthetic valve infective endocarditis, a challenging infection of heart valve replacements. This exploratory Phase 2 study compares the diagnostic accuracy of 68Ga-PETCT with the standard 18F-fluorodeoxyglucose PETCT 18FDG-PETCT, based on final diagnoses determined by expert review after three months using the 2023 European Society of Cardiology criteria. The study aims to address limitations of 18FDG-PETCT, especially in patients who find it difficult to follow dietary restrictions before the exam. Participants suspected of having infective endocarditis on prosthetic heart valves will undergo both imaging tests, with 68Ga-PETCT performed either the day before, the same day, or the day after 18FDG-PETCT. Both scans will be interpreted independently by experienced nuclear medicine physicians who are unaware of the final diagnosis. This allows a direct comparison of the two imaging methods ability to detect infection. During the study, participants will be followed for three months to confirm the diagnosis through expert panel review using clinical, microbiological, and imaging data according to ESC 2023 guidelines. Researchers will measure the sensitivity of 68Ga-PETCT for detecting prosthetic valve infection and compare its accuracy and agreement with the standard 18FDG-PETCT. Safety and interpretation consistency between readers will also be monitored throughout the observation period.

Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis