New scan could shine a light on hidden inflammation
NCT ID NCT07535554
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new radioactive tracer called [18F]AlF-FAPI-74 for PET/CT scans to see if it can find inflammation better than the current standard tracer. The trial will involve 140 people with fever of unknown origin, IgG4-related disease, or axial spondylarthritis. Researchers will compare the new tracer's ability to pinpoint inflammation and help make a diagnosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]AlF-FAPI-74 (a radioactive tracer for PET/CT scans)
- What this could lead to
- If successful, this could provide a more accurate way to diagnose inflammatory diseases, potentially reducing the need for invasive biopsies and guiding treatment more effectively.
- What could go wrong
- This is a mid-stage study with only 140 participants, so results may not apply to everyone. The new tracer may not prove superior to the current standard, and its availability could be limited.
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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 FUO: * An illness of more than 3 weeks' duration, * Temperature exceeding 38.3°C on \> 3 occasions, or elevated inflammatory markers on \> 3 occasions * Diagnosis uncertain despite appropriate first-line investigations. Inclusion criteria IgG4-RD: * High clinical suspicion of IgG4-RD by an experienced clinician of Internal Medicine, based on anamnesis, physical examination, first-line investigations and blood tests. * Patients with a new diagnosis of IgG4-RD on histopathology and need for further assessment of disease extent with PET/CT, * Relapse of diagnosed IgG4-RD on histopathology according to an experienced clinician of Internal Medicine Inclusion criteria AxSpA: * High clinical suspicion of axial spondyloarthropahy according to an experienced rheumatology (based on inflammary back pain \> 3 months, insidious onset, morning stifness, improvement with exercise and worsening in rest, pain worse at night, age at onset \<45 years of age, imaging findings). * Patient has persisting inflammatory back pain after 2 different types of NSAID's (tried for over 2-4 weeks), and is therefore eligible for biological DMARDS therapy. Exclusion Criteria: * Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures. * Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol. * Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial. * Female who is pregnant (urinary hCG test will be performed in every WOCBP), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted). * Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team. * Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv. * Participant has a known hypersensitivity to \[18F\]AlF-FAPI-74 or the used excipients. * Active treatment has already commenced
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital Leuven
RECRUITINGLeuven, 3000, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Investigational drug AMG 335 offered to adults with IgG4-Related disease
- Can inhaled cell vesicles soothe damaged lungs in autoimmune disease?
- Can engineered immune cells tame a stubborn autoimmune disease?
- Can a dashboard turn patient data into better arthritis care?
- New drug aims to stop IgG4 disease relapses without Long-Term steroids