A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis
Key facts
- Who runs it
- Turku University Hospital
- Where
- Helsinki, Pori, and Turku, FinlandSee the 3 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 143 people, planned
- Started
- 14 Sept 2026
- Expected to end
- 31 Dec 2030
- Type of study
- Interventional, 3 groups
- Treatments tested
- Al[¹⁸F]F-NOTA-folate PET imaging
- [15O]water PET imaging
- Echocardiography
- Record updated
- 21 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Finland
- HUS-YhtymaeHelsinki, FinlandNot yet recruiting
- SatasairaalaPori, FinlandNot yet recruiting
- Turku University HospitalTurku, FinlandNot yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- Suspected cardiac sarcoidosisTreatment being tested
Patients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
Treatment: Al[¹⁸F]F-NOTA-folate PET imaging, [15O]water PET imaging, and Echocardiography
- Suspected infective endocarditisTreatment being tested
Patients with suspected infective endocarditis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
Treatment: Al[¹⁸F]F-NOTA-folate PET imaging
- Healthy volunteersTreatment being tested
Healthy volunteers without known cardiovascular or systemic inflammatory disease.
Treatment: Al[¹⁸F]F-NOTA-folate PET imaging
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis (FOL-CARD)
- Record updated
- 21 September 2026