A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis (NCT06335888) | Clinical Trial Compass
RecruitingPhase 2
A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Switzerland70 participantsStarted 2025-02-03
Plain-language summary
The goal of this open-label clinical trial is to evaluate the efficacy of AzaFol-PET/CT in the diagnosis of GCA (giant cell arteritis), to compare AzaFol- with 2-\[18F\]FDG-PET/CT, and to assess the safety and tolerability of AzaFol in subjects with suspicion of GCA.
Participants will undergo AzaFol-PET/CT imaging at a single timepoint.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Folate deficiency
. Female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study or within 30 days after the last dose of study drug
. Concomitant treatment with medications that lead to a significant impairment of folic acid levels (methotrexate, pemetrexed, raltitrexed)
. Concomitant glucose-containing infusion or parental nutrition within 6 hours prior to 2-\[18F\]FDG tracer application
. Glucose level \> 10 mmol/l at the timepoint of 2-\[18F\]FDG PET/CT
. Unable to remain in the PET/CT for the duration of the examination
. Unable to lie still for the duration of the examination (45 min)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Specificity of the GCA-diagnosis at the patient level