NCT06335888 A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
| NCT ID | NCT06335888 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Giant Cell Arteritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2025-02-03 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Individuals ≥ 50 years with clinical suspicion of GCA * Women of childbearing potential must not have a positive serum pregnancy test at the Screening Visit * Subjects must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. * Are willing and able to comply with procedures required in this protocol. Exclusion Criteria: 1. Folate deficiency 2. Female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study or within 30 days after the last dose of study drug 3. Concomitant treatment with medications that lead to a significant impairment of folic acid levels (methotrexate, pemetrexed, raltitrexed) 4. Concomitant glucose-containing infusion or parental nutrition within 6 hours prior to 2-\[18F\]FDG tracer application 5. Glucose level \> 10 mmol/l at the timepoint of 2-\[18F\]FDG PET/CT 6. Unable to remain in the PET/CT for the duration of the examination 7. Unable to lie still for the duration of the examination (45 min) 8. Unable not to eat or drink (except water) for 6 hours prior to 2-\[18F\]FDG tracer application 9. Prior PET-imaging within 60 days before baseline 10. Intake of vitamin supplements containing \> 1mg/day folic acid within 48 h prior to the PET/CT with AzaFol 11. Known hypersensitivity or allergy to folic acid 12. Enrolment of the investigator, his/her family members, employees and other dependent persons 13. Participation in another study with investigational drug within the 7 days preceding and during the present study.
Contact & Investigator
Britta Maurer
PRINCIPAL INVESTIGATOR
Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland
Frequently Asked Questions
Who can join the NCT06335888 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Giant Cell Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06335888 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06335888 currently recruiting?
Yes, NCT06335888 is actively recruiting participants. Contact the research team at RI-Studien@insel.ch for enrollment information.
Where is the NCT06335888 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06335888 clinical trial?
NCT06335888 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Britta Maurer at Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland. The trial plans to enroll 70 participants.