A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis

Ki vehet részt

• Ability to provide written informed consent
• Suspected cardiac sarcoidosis group: clinical suspicion of cardiac sarcoidosis requiring diagnostic evaluation, including cardiac magnetic resonance and/or [¹⁸F]FDG PET
• Suspected infective endocarditis group: clinical suspicion of native or prosthetic valve infective endocarditis requiring diagnostic evaluation
• Healthy volunteers group:
• Age above 50 and post-menopausal (women)
• No history of cardiovascular disease, systemic inflammatory disease, malignancy, and no active infection

Ki nem vehet részt

• Systemic immunosuppressive therapy for more than 7 days prior to baseline Al[18F]F-NOTA-folate PET imaging
• Women of childbearing potential must have a negative pregnancy test prior to tracer administration
• Known hypersensitivity to folate-based compounds or investigational medical product excipients
• Clinically unstable condition that, in the opinion of the investigator, would make study imaging unsafe or not feasible (e.g., haemodynamic instability, decompensated heart failure, uncontrolled clinically significant arrhythmia, suspicion of acute coronary syndrome)
• Severe renal impairment (CKD-EPI GFR <20ml/min)
• Pregnancy or breastfeeding
• Unwillingness or inability to use effective contraception during the study participation period, in participants of childbearing potential
• Inability to complete protocol-defined study procedures