Al[18F]F-NOTA-folate PET imaging in suspected cardiac sarcoidosis and infective endocarditis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective diagnostic study evaluates the imaging features, diagnostic performance, radiation dose, and safety of Al[18F]F-NOTA-folate PET in patients with suspected cardiac sarcoidosis or infective endocarditis, plus healthy volunteers. It is non-interventional for clinical management, with decisions made per standard care independent of participation. The study measures tracer uptake in the left ventricle for cardiac sarcoidosis and in cardiac valves or prosthetic valve regions for endocarditis, using PET imaging at the Turku PET Centre. A second PET scan after immunosuppressive therapy is planned for suspected cardiac sarcoidosis patients. Additional modalities include [15O]water PET imaging and echocardiography as part of the assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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)
* Systemic immunosuppressive therapy for more than 7 days prior to baseline Al\[18F\]F-NOTA-folate PET imaging
* Inability to complete protocol-defined study procedures
* Women of childbearing potential must have a negative pregnancy test prior to tracer administration

Where it's running

• Turku University Hospital
  Turku, Finland Recruiting

Study contacts

• Study coordinator: Antti Saraste, Professor
• Email: antti.saraste@utu.fi
• Phone: 00358 50 4499979

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.