The goal of this prospective diagnostic study is to evaluate the imaging characteristics, diagnostic performance, radiation dosimetry, and safety of Al\[¹⁸F\]F-NOTA-folate PET imaging in patients with suspected cardiac sarcoidosis and infective endocarditis, and healthy volunteers. The study is non-interventional with respect to clinical management, and all diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
The main aims are to evaluate quantitative uptake of Al\[¹⁸F\]F-NOTA-folate measured by PET imaging in the left ventricular myocardium of patients with suspected cardiac sarcoidosis, and in cardiac valves or prosthetic valve regions in patients with suspected infective endocarditis.
Participants will undergo PET imaging with Al\[¹⁸F\]F-NOTA-folate tracer at the Turku PET Centre. Participants with suspected cardiac sarcoidosis will undergo a second PET imaging study after initiation of immunosuppressive therapy.
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
Age above 50 and post-menopausal (women)
Pregnancy or breastfeeding
Known hypersensitivity to folate-based compounds or investigational medical product excipients
Unwillingness or inability to use effective contraception during the study participation period, in participants of childbearing potential
Severe renal impairment (CKD-EPI GFR <20ml/min)
Single group
Al[¹⁸F]F-NOTA-folate PET imaging
Diagnostic testImaging is performed in all study groups to assess myocardial, valvular, and extracardiac tracer uptake using a total-body PET/CT system (Siemens Quadra, Siemens Healthcare, Erlangen, Germany). Imaging will cover the region from head to mid-thighs to enable assessment of both cardiac and extracardiac tracer uptake. Serum and plasma samples, ECG and vital signs are collected during the imaging study visit.
[15O]water PET imaging
Diagnostic testResting myocardial perfusion imaging using \[15O\]water PET is performed only in patients with suspected cardiac sarcoidosis to assess myocardial perfusion and support interpretation of Al\[18F\]F-NOTA-folate uptake.
Echocardiography
Diagnostic testTransthoracic echocardiography (GE Vivid 95, GE Healthcare, Hjorten, Norway) will be performed in patients with suspected cardiac sarcoidosis to assess left ventricular structure and function. Acquisition and analysis will follow standard clinical protocols. Echocardiography will be performed during the same visits as PET imaging.
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in the left ventricular myocardium in patients with suspected cardiac sarcoidosis.
Quantitative uptake of Al\[¹⁸F\]F-NOTA-folate on PET in the left ventricular myocardium (global and regional standardized uptake value (SUV) measures derived from polar map analysis) in suspected cardiac sarcoidosis.
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in infected versus non-infected cardiac valves or prostheses in patients with suspected infective endocarditis
Quantitative uptake of Al\[¹⁸F\]F-NOTA-folate on PET in the valve/prosthesis region in suspected infective endocarditis (SUVmax and TBR = SUVmax valve/prosthesis / SUVmean blood pool).
Diagnostic performance of Al[¹⁸F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis
Change in myocardial Al[¹⁸F]F-NOTA-folate uptake following immunosuppressive therapy in cardiac sarcoidosis
Patients with confirmed CS may undergo optional follow-up static PET imaging with Al\[¹⁸F\]F-NOTA-folate and \[¹⁵O\]water approximately 3 months after baseline imaging to assess changes in inflammatory activity following initiation of immunosuppressive therapy.
Biodistribution and radiation dosimetry of Al[¹⁸F]F-NOTA-folate
Healthy volunteers will undergo extended imaging, including dynamic imaging for 120 min starting at the time of tracer injection + static imaging for 10 minutes at 150 min after tracer injection to support analysis of tracer kinetics and biodistribution, and radiation dosimetry calculations.
Incidence and severity of adverse events related to Al[¹⁸F]F-NOTA-folate
Incidence and severity of adverse events (AE) and adverse reactions; clinically significant changes in vital signs or ECG; changes in safety laboratory parameters (healthy volunteers); clinically indicated laboratory assessments performed in the event of an adverse event (as applicable); and investigator assessment of relationship to Al\[¹⁸F\]F-NOTA-folate.
Associations between myocardial Al[¹⁸F]F-NOTA-folate uptake and other parameters collected during study visits, and adverse cardiac events during follow-up in patients with suspected cardiac sarcoidosis.
Other measured parameters include left ventricular function, myocardial perfusion, and circulating and imaging biomarkers of myocardial injury or inflammation.
Associations between valvular Al[¹⁸F]F-NOTA-folate uptake and clinical events in patients with suspected infective endocarditis.
Clinical events include duration of antibiotic therapy, causative micro-organism, systemic inflammatory parameters, anatomical valvular lesions, need for cardiac surgery and adverse cardiac events during follow-up.
Extra-cardiac inflammatory or infectious foci.
Detection and characterisation of extra-cardiac inflammatory or infectious foci on whole-body Al\[¹⁸F\]F-NOTA-folate PET imaging.
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Turku University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Satasairaala
Collaborator
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