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

Prior treatment

• 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.

Other illness

• 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

Other

• 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).

• 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.