SODIUM FLUORIDE (18F) for Psoriasis

Inclusion criteria

• {"criterion_text":"- Patients with a diagnosis of psoriasis and an age of 18 years or older\n- ≥1 arthralgia and/or enthesiopathy in ≥1 location(s) ≤ 1 year, not secondary to trauma\n- ≥1 of the following: Nail psoriasis, First-degree relative with PsA and/or BSA ≥3%"}

Exclusion criteria

• {"criterion_text":"- Other rheumatic disease (such as Axial SpA, RA, SLE, Sjögren)\n- Osteoarthritis and/or mechanical explanation of the pain in joints and/or tendons\n- Clinically evident arthritis (and/or tenosynovitis)\n- Systemic therapy for psoriasis (DMARD, bDMARD)\n- Treatment with study medication in the past 3 months\n- Pregnancy or breast-feeding"}

Primary endpoints

• {"endpoint_text":"- The number of individuals with PET-positive lesions and the distribution of PET-positive lesions.","definition_or_measurement_approach":"Detection by whole body [18F]Fluoride PET-CT scans to identify PET-positive lesions; count of individuals with PET-positive lesions and assessment of lesion distribution."}

Secondary endpoints

• {"endpoint_text":"- The correlation between PET outcome and development of PsA in 2 years follow-up","definition_or_measurement_approach":"Correlation between PET outcome and the development of psoriatic arthritis during a 2-year follow-up period."}
• {"endpoint_text":"- The quantitative [18F]Fluoride uptake in PET-positive lesions","definition_or_measurement_approach":"Quantitative measurement of [18F]Fluoride uptake in PET-positive lesions using PET imaging metrics."}

Netherlands

Earliest CTIS Part Ii Submission Date

05-12-2024

Latest Decision Or Authorization Date

16-12-2024

Processing Time Days

11

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Stichting Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands