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

9. září 2026 aktualizováno: Turku University Hospital

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

143

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Antti Saraste, Professor
  • Telefonní číslo: 00358 50 4499979
  • E-mail: antti.saraste@utu.fi

Studijní záloha kontaktů

Studijní místa

  • Finsko
      • Turku, Finsko, 20520
        • Turku University Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Suspected cardiac sarcoidosis
Patients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
Diagnostický test: Al[¹⁸F]F-NOTA-folate PET imaging
Imaging 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.
Ostatní jména:
  • Al[¹⁸F]F-NOTA-folate
Diagnostický test: [15O]water PET imaging
Resting 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.
Diagnostický test: Echocardiography
Transthoracic 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.
Experimentální: Suspected infective endocarditis
Patients with suspected infective endocarditis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
Diagnostický test: Al[¹⁸F]F-NOTA-folate PET imaging
Imaging 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.
Ostatní jména:
  • Al[¹⁸F]F-NOTA-folate
Experimentální: Healthy volunteers
Healthy volunteers without known cardiovascular or systemic inflammatory disease.
Diagnostický test: Al[¹⁸F]F-NOTA-folate PET imaging
Imaging 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.
Ostatní jména:
  • Al[¹⁸F]F-NOTA-folate

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in the left ventricular myocardium in patients with suspected cardiac sarcoidosis.
Časové okno: Visit 2 (baseline imaging), no later than 7 days after initiation of systemic immunosuppressive therapy.
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.
Visit 2 (baseline imaging), no later than 7 days after initiation of systemic immunosuppressive therapy.
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
Časové okno: Visit 2 (baseline imaging), performed within 14 days of enrolment and no later than 14 days after initiation of intravenous antibiotic therapy.
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).
Visit 2 (baseline imaging), performed within 14 days of enrolment and no later than 14 days after initiation of intravenous antibiotic therapy.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Diagnostic performance of Al[¹⁸F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis
Časové okno: From enrollment to study completion at 2 years.
From enrollment to study completion at 2 years.
Change in myocardial Al[¹⁸F]F-NOTA-folate uptake following immunosuppressive therapy in cardiac sarcoidosis
Časové okno: From Visit 2 (baseline imaging) to Visit 3 (follow-up imaging). Visit 2 is performed 7 days after initiation of systemic immunosuppressive therapy and Visit 3 is performed approximately 3 months after baseline imaging.
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.
From Visit 2 (baseline imaging) to Visit 3 (follow-up imaging). Visit 2 is performed 7 days after initiation of systemic immunosuppressive therapy and Visit 3 is performed approximately 3 months after baseline imaging.
Biodistribution and radiation dosimetry of Al[¹⁸F]F-NOTA-folate
Časové okno: Visit 2 (imaging), performed 7-14 days after Visit 1 (screening and enrolment).
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.
Visit 2 (imaging), performed 7-14 days after Visit 1 (screening and enrolment).
Incidence and severity of adverse events related to Al[¹⁸F]F-NOTA-folate
Časové okno: Suspected sarcoidosis and infective endocarditis groups: from Visit 2 (baseline imaging) to study completion at 2 years. Healthy volunteers: from Visit 2 to 48-72 hours, when safety laboratory tests will be obtained and AEs assessed by phone interview.
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.
Suspected sarcoidosis and infective endocarditis groups: from Visit 2 (baseline imaging) to study completion at 2 years. Healthy volunteers: from Visit 2 to 48-72 hours, when safety laboratory tests will be obtained and AEs assessed by phone interview.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: From enrollment to end of follow-up at 2 years.
Other measured parameters include left ventricular function, myocardial perfusion, and circulating and imaging biomarkers of myocardial injury or inflammation.
From enrollment to end of follow-up at 2 years.
Associations between valvular Al[¹⁸F]F-NOTA-folate uptake and clinical events in patients with suspected infective endocarditis.
Časové okno: From study enrollment to end of follow-up at 2 years.
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.
From study enrollment to end of follow-up at 2 years.
Extra-cardiac inflammatory or infectious foci.
Časové okno: Suspected sarcoidosis group: Visit 2 (baseline imaging, for details see primary outcome measure) and Visit 3 (follow-up imaging after 3 months). Suspected infective endocarditis group: Visit 2 (baseline imaging, for details see primary outcome measure).
Detection and characterisation of extra-cardiac inflammatory or infectious foci on whole-body Al[¹⁸F]F-NOTA-folate PET imaging.
Suspected sarcoidosis group: Visit 2 (baseline imaging, for details see primary outcome measure) and Visit 3 (follow-up imaging after 3 months). Suspected infective endocarditis group: Visit 2 (baseline imaging, for details see primary outcome measure).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Turku University Hospital

Spolupracovníci

Helsinki University Central Hospital
Satasairaala

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

14. září 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2030

Termíny zápisu do studia

První předloženo

7. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

9. září 2026

První zveřejněno (Aktuální)

10. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. září 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 13119
  • 2026-526655-59-00 (Ctis)

Plán pro data jednotlivých účastníků (IPD)

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NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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