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Macrophage imaging GCA
EU CTIS ID: 2024-514491-40-00
What this study is testing
Primary Objective: to evaluate 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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Age ≥ 50 years at time of disease onset - Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L - 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). - Imaging findings consistent with large vessel GCA at the time of inclusion (e.g. ultrasound, FDG-PET/CT) - Patients must be able to adhere to the study appointments and other protocol requirements. - Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.
You likely can't join if
- - 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). - Ultrasound findings consistent with cranial GCA (e.g. halo sign in temporal or facial artery). - A prior positive temporal artery biopsy. - Initiation or dose escalation of systemic glucocorticoid therapy (oral, IM, IV) in the 4 weeks prior to inclusion - Initiation or dose escalation of disease-modifying antirheumatic drugs (DMARDs) within 3 months prior to inclusion - Treatment with any investigational drug within 3 months prior to inclusion. - 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. - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.