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

NCT07814222 | Recruiting

• 2 other identifiers: 131192026-526655-59-00
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Sarcoidosis; Infective Endocarditis

Keywords

folate; positron emission tomography; pet; infective endocarditis; cardiac sarcoidosis; diagnostic study

Outcome Measures

Primary Outcomes (2)

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

  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

  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.

Secondary Outcomes (4)

• Diagnostic performance of Al[¹⁸F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis

  From enrollment to study completion at 2 years.

• Change in myocardial Al[¹⁸F]F-NOTA-folate uptake following immunosuppressive therapy in cardiac sarcoidosis

  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

  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

  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.

Other Outcomes (3)

• 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.

  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.

  From study enrollment to end of follow-up at 2 years.

• Extra-cardiac inflammatory or infectious foci.

  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).

Study Arms (3)

Suspected cardiac sarcoidosis

EXPERIMENTAL

Patients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.

Diagnostic Test: Al[¹⁸F]F-NOTA-folate PET imaging; Diagnostic Test: [15O]water PET imaging; Diagnostic Test: Echocardiography

Suspected infective endocarditis

EXPERIMENTAL

Patients with suspected infective endocarditis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation.

Diagnostic Test: Al[¹⁸F]F-NOTA-folate PET imaging

Healthy volunteers

EXPERIMENTAL

Healthy volunteers without known cardiovascular or systemic inflammatory disease.

Diagnostic Test: Al[¹⁸F]F-NOTA-folate PET imaging

Interventions

Al[¹⁸F]F-NOTA-folate PET imaging DIAGNOSTIC_TEST

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.

Also known as: Al[¹⁸F]F-NOTA-folate

Healthy volunteers; Suspected cardiac sarcoidosis; Suspected infective endocarditis

[15O]water PET imaging DIAGNOSTIC_TEST

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.

Suspected cardiac sarcoidosis

Echocardiography DIAGNOSTIC_TEST

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.

Suspected cardiac sarcoidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Satasairaala: collaborator

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

RECRUITING

MeSH Terms

Conditions

Endocarditis; Disease

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Antti Saraste, Professor

CONTACT

00358 50 4499979; antti.saraste@utu.fi

Tuija Vasankari, MSc

CONTACT

tuija.vasankari@varha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: In this diagnostic interventional study, there are three different subgroups, who all get the same intervention (diagnostic test: folate PET). The analysis are conducted within the subgroups.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: September 10, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)