Cardiac SarcoidosisFOL-CARDNCT07814222
A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis
A study testing Al[¹⁸F]F-NOTA-folate PET imaging, [15O]water PET imaging and Echocardiography in people with Cardiac Sarcoidosis and Infective Endocarditis, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Sarcoidosis, Infective Endocarditis
- What is being tested?
- Al[¹⁸F]F-NOTA-folate PET imaging, [15O]water PET imaging and Echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteFinland
- Study dates
- 14 Sep 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tuija Vasankari, MSc contact
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20520
Sanna Laurila, MD PhD, 00358 50 459 0097, sanna.laurila@varha.fi
About this study
Official title: 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.
- Conditions
- Cardiac Sarcoidosis, Infective Endocarditis
- Being tested
- Al[¹⁸F]F-NOTA-folate PET imaging, [15O]water PET imaging, Echocardiography
- Keywords
- folate, positron emission tomography, pet, infective endocarditis, cardiac sarcoidosis, diagnostic study
- Medical subject headings
- Endocarditis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al[¹⁸F]F-NOTA-folate PET imagingDiagnostic test
Also called Al[¹⁸F]F-NOTA-folate
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.
[15O]water PET imagingDiagnostic 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.
EchocardiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Al[¹⁸F]F-NOTA-folate PET imaging |
| Healthy volunteers | Experimental | Healthy volunteers without known cardiovascular or systemic inflammatory disease. Receives: Diagnostic Test: Al[¹⁸F]F-NOTA-folate PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: From enrollment to study completion at 2 years.
Change in myocardial Al[¹⁸F]F-NOTA-folate uptake following immunosuppressive therapy in cardiac sarcoidosis
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Helsinki University Central Hospital, Satasairaala
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814222
- Sponsor's protocol ID
- 13119
- Other IDs
- 2026-526655-59-00
- Acronym
- FOL-CARD
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Diagnostic Trial of Al[¹⁸F]F-NOTA-folate PET in Patients With Suspected Cardiac Sarcoidosis and Infective Endocarditis (FOL-CARD)
- ClinicalTrials.gov ID
- NCT07814222
- Acronym / sponsor ID
- FOL-CARD / 13119
- Conditions
- Cardiac Sarcoidosis, Infective Endocarditis
- Keywords
- folate, positron emission tomography, pet, infective endocarditis, cardiac sarcoidosis, diagnostic study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Helsinki University Central Hospital, Satasairaala
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Suspected cardiac sarcoidosis | Experimental | Diagnostic Test: Al[¹⁸F]F-NOTA-folate PET imaging, Diagnostic Test: [15O]water PET imaging, Diagnostic Test: EchocardiographyPatients with suspected cardiac sarcoidosis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation. |
| Suspected infective endocarditis | Experimental | Diagnostic Test: Al[¹⁸F]F-NOTA-folate PET imagingPatients with suspected infective endocarditis. All diagnostic and therapeutic decisions are made according to routine clinical practice independent of study participation. |
| Healthy volunteers | Experimental | Diagnostic Test: Al[¹⁸F]F-NOTA-folate PET imagingHealthy volunteers without known cardiovascular or systemic inflammatory disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Al[¹⁸F]F-NOTA-folate PET imagingAlso: Al[¹⁸F]F-NOTA-folateImaging 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. | Diagnostic test | Healthy volunteers, Suspected cardiac sarcoidosis, Suspected infective endocarditis |
| [15O]water PET imagingResting 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. | Diagnostic test | Suspected cardiac sarcoidosis |
| EchocardiographyTransthoracic 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. | Diagnostic test | Suspected cardiac sarcoidosis |
Primary outcome
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in the left ventricular myocardium in patients with suspected cardiac sarcoidosis.
Time frame: 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.
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
Time frame: 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).
4 secondary outcomes
Diagnostic performance of Al[¹⁸F]F-NOTA-folate PET for cardiac sarcoidosis and native or prosthetic valve infective endocarditis
Time frame: From enrollment to study completion at 2 years.
Change in myocardial Al[¹⁸F]F-NOTA-folate uptake following immunosuppressive therapy in cardiac sarcoidosis
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuija Vasankari, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Al[¹⁸F]F-NOTA-folate PET imaging, [15O]water PET imaging and Echocardiography in people with Cardiac Sarcoidosis and Infective Endocarditis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antti Saraste, Professor (00358 50 4499979, antti.saraste@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative uptake of Al[¹⁸F]F-NOTA-folate measured by PET in the left ventricular myocardium in patients with suspected cardiac sarcoidosis. (time frame: Visit 2 (baseline imaging), no later than 7 days after initiation of systemic immunosuppressive therapy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.