NCT07535554 The Investigators Will Evaluate the Diagnostic Performance of [18F]-AlF-FAPI-74 PET/CT in Inflammatory Disorders and Compare it With the Current Gold Standard for Inflammation, FDG PET/CT, in Three Patient Cohort: Patients Presenting With Fever of Unknown Origin, IgG4-RD and AxSpA.
| NCT ID | NCT07535554 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Fever of Unknown Origin |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2025-09-17 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study to evaluate the performance of new \[18F\]-AlF-FAPI-74 PET/CT in three inflammatory disorders (fever of unknown origin, IgG4-related disease and axial spondyloarthritis) and compare with the current stand-of-care \[18F\]-FDG PET/CT
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07535554 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fever of Unknown Origin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07535554 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07535554 currently recruiting?
Yes, NCT07535554 is actively recruiting participants. Contact the research team at lennert.boeckxstaens@uzleuven.be for enrollment information.
Where is the NCT07535554 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT07535554 clinical trial?
NCT07535554 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 140 participants.