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Folate tracer lights up inflamed hearts in PET scan study

NCT ID NCT07814222

Diagnosis Sponsor: Turku University Hospital Source: ClinicalTrials.gov ↗

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Sep 10, 2026 · Last updated Sep 21, 2026 · Updated 2 times

Summary

Researchers at Turku University Hospital are testing a PET imaging tracer called Al[18F]F-NOTA-folate to see how well it detects two heart conditions: cardiac sarcoidosis, an inflammatory disease of the heart muscle, and infective endocarditis, an infection of the heart valves. The study enrolls people with suspected cardiac sarcoidosis, people with suspected infective endocarditis, and healthy volunteers over 50. All participants receive the tracer and undergo PET scans; those with suspected sarcoidosis may have a second scan after starting immunosuppressive therapy. The goal is to measure how much tracer collects in heart muscle and valves, and to assess the scan's diagnostic performance, radiation dose, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Al[18F]F-NOTA-folate, an experimental PET imaging tracer that targets folate receptors
What this could lead to
If the tracer works, doctors could gain a non-invasive way to tell inflamed heart muscle from infected valves, guiding treatment without invasive biopsies.
What could go wrong
This is a diagnostic accuracy study, not a treatment. The tracer may not light up diseased tissue clearly enough, and results from 143 people may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 143 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cardiac sarcoidosis disease endocarditis infective endocarditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac sarcoidosis Infective endocarditis

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Turku University Hospital

    RECRUITING

    Turku, 20520, Finland

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