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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 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

143

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Antti Saraste, Professor
  • Número de teléfono: 00358 50 4499979
  • Correo electrónico: antti.saraste@utu.fi

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Finlandia
      • Turku, Finlandia, 20520
        • Turku University Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Suspected cardiac sarcoidosis
Patients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
Prueba de diagnóstico: 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.
Otros nombres:
  • Al[¹⁸F]F-NOTA-folate
Prueba de diagnóstico: [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.
Prueba de diagnóstico: 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.
Experimental: Suspected infective endocarditis
Patients with suspected infective endocarditis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.
Prueba de diagnóstico: 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.
Otros nombres:
  • Al[¹⁸F]F-NOTA-folate
Experimental: Healthy volunteers
Healthy volunteers without known cardiovascular or systemic inflammatory disease.
Prueba de diagnóstico: 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.
Otros nombres:
  • Al[¹⁸F]F-NOTA-folate

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in the left ventricular myocardium in patients with suspected cardiac sarcoidosis.
Periodo de tiempo: 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
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Diagnostic performance of Al[¹⁸F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Turku University Hospital

Colaboradores

Helsinki University Central Hospital
Satasairaala

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

14 de septiembre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

7 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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