Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

9. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

143

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Finland
      • Turku, Finland, 20520
        • Turku University Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Suspected cardiac sarcoidosis
Patients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
Diagnostisk 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.
Andre navn:
  • Al[¹⁸F]F-NOTA-folate
Diagnostisk 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.
Diagnostisk 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.
Eksperimentell: Suspected infective endocarditis
Patients with suspected infective endocarditis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
Diagnostisk 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.
Andre navn:
  • Al[¹⁸F]F-NOTA-folate
Eksperimentell: Healthy volunteers
Healthy volunteers without known cardiovascular or systemic inflammatory disease.
Diagnostisk 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.
Andre navn:
  • Al[¹⁸F]F-NOTA-folate

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in the left ventricular myocardium in patients with suspected cardiac sarcoidosis.
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic performance of Al[¹⁸F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Turku University Hospital

Samarbeidspartnere

Helsinki University Central Hospital
Satasairaala

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

14. september 2026

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

7. august 2026

Først innsendt som oppfylte QC-kriteriene

9. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere