Prospective diagnostic performance of PET/CT using the novel fibroblast imaging tracer [18F]-AlF-FAPI-74 versus power doppler ultrasound in psoriasis patients with arthralgia: early detection of psoriatic arthritis
Key facts
- Where
- Edegem és Leuven, BelgiumSee the 2 sites
- Phase
- 2/3. fázis
Where in Belgium
- Universitair Ziekenhuis AntwerpenEdegem, BelgiumToborzás még nem indult
- UZ LeuvenLeuven, BelgiumToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UZ Leuven
- Trial code
- EU 2026-526942-29-00
- Record updated
- 2026. október 16.
- Original description
Demonstrate that the diagnostic/predictive performance of [18F] AlF-FAPI-74 PET/CT is equivalent or superior to the current gold standard, power doppler ultrasound, for the development of clinical psoriatic arthritis within 2 years (non-inferiority study with non-inferiority limit 10%) in psoriasis patients with arthralgiasRead full original descriptionShow less
Demonstrate that the diagnostic/predictive performance of [18F] AlF-FAPI-74 PET/CT is equivalent or superior to the current gold standard, power doppler ultrasound, for the development of clinical psoriatic arthritis within 2 years (non-inferiority study with non-inferiority limit 10%) in psoriasis patients with arthralgias
Inclusion: Voluntary written informed consent must be obtained prior to any screening procedures; Subject is aged > 18 years; Female subjects should be (a) post-menopausal, or (b) surgically sterile, or (c) using effective contraceptive with negative pregnancy test; Patients need to have a dermatologist confirmed clinical diagnosis of psoriasis, either plaque psoriasis, guttate psoriasis or pustular; Patient has persisting (inflammatory) arthralgia of the peripheral joints or entheses for more than 2 weeks, but less than 2 years not caused by trauma and with a morning stiffness of more than 10 minutes.
Exclusion: Participation in a clinical scientific trial in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv; Use of systemic immunosuppressive therapy, including treatment with bDMARDs or tDMARDS, for psoriasis or another condition already started before study scan; Current or history of other inflammatory arthritis; Participant has a known hypersensitivity to [18F] AlF-FAPI-74 or the used excipients; Diagnosis of other generalized dermatological conditions, such as atopic dermatitis, SLE, ……; History or presence of malignancy; Any disorder or condition, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol; 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; Contraindication to PET scan (pregnancy, claustrophobia ……); Patients with peripheral joint replacement; Participant is mentally or legally incapacitated, do not understand the trial design or is not willing or capable to undergo all trial-specific procedures; 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).