[18F]FLUORO-PEG-FOLATE for Giant cell arteritis|Large-vessel giant cell arteritis

Inclusion criteria

• {"criterion_text":"- Age ≥ 50 years at time of disease onset"}
• {"criterion_text":"- Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L"}
• {"criterion_text":"- Clinical symptoms of large vessel GCA (at least one of the following) at time of inclusion: constitutional symptoms (fatigue, fever, weight loss, and/or night sweats), limb claudication, or symptoms of polymyalgia rheumatica (i.e. shoulder and/or hip girdle pain associated with morning stiffness)."}
• {"criterion_text":"- Imaging findings consistent with large vessel GCA at the time of inclusion (e.g. ultrasound, FDG-PET/CT)"}
• {"criterion_text":"- Patients must be able to adhere to the study appointments and other protocol requirements."}
• {"criterion_text":"- Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures."}

Exclusion criteria

• {"criterion_text":"- Clinical symptoms suggestive of cranial GCA (at least one of the following): new-onset localized headache, scalp tenderness, temporal artery abnormality (thickening, tenderness, and/or decreased pulsation), ischemia-related vision loss, stroke, transients ischemic attack, jaw or tongue claudication (pain upon mastication)."}
• {"criterion_text":"- Ultrasound findings consistent with cranial GCA (e.g. halo sign in temporal or facial artery)."}
• {"criterion_text":"- A prior positive temporal artery biopsy."}
• {"criterion_text":"- Initiation or dose escalation of systemic glucocorticoid therapy (oral, IM, IV) in the 4 weeks prior to inclusion"}
• {"criterion_text":"- Initiation or dose escalation of disease-modifying antirheumatic drugs (DMARDs) within 3 months prior to inclusion"}
• {"criterion_text":"- Treatment with any investigational drug within 3 months prior to inclusion."}
• {"criterion_text":"- Females with child bearing potential. Post-menopausal women with >12 months of amenorrhoea are considered to have no child bearing potential. Given the age distribution of patients with GCA, exclusion of females with child bearing potential will not lead to recruitment bias in the study."}
• {"criterion_text":"- Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion."}

Primary endpoints

• {"endpoint_text":"- Arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.","definition_or_measurement_approach":"Arterial uptake of [18F]fluor-PEG-folate measured on PET/CT in patients with active large-vessel GCA at baseline and compared in the same patients after 9 months of standard treatment (measurement described as PET/CT uptake; no further quantitative method specified in source)."}

Netherlands

Earliest CTIS Part Ii Submission Date

10-09-2024

Latest Decision Or Authorization Date

11-09-2024

Processing Time Days

1

Number Of Sites

2

Number Of Participants

10

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands