A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
NCT ID: NCT06335888
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2025-02-03
2029-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participants will undergo AzaFol-PET/CT imaging at a single timepoint.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
NCT00307671
Biomarkers in Giant Cells Arteritis
NCT02844023
Giant Cell Arteritis - Ways to Precision Medicine
NCT07084480
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
NCT04012905
Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients
NCT04299971
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AzaFol first, FDG second
AzaFol PET/CT imaging followed by FDG PET/CT imaging (standard of care)
AzaFol
AzaFol-PET/CT imaging
FDG
FDG-PET/CT imaging
FDG first, AzaFol second
FDG PET/CT imaging (standard of care) imaging followed by AzaFol PET/CT
AzaFol
AzaFol-PET/CT imaging
FDG
FDG-PET/CT imaging
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AzaFol
AzaFol-PET/CT imaging
FDG
FDG-PET/CT imaging
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Paul Scherrer Institut, Center for Proton Therapy
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Britta Maurer
Role: PRINCIPAL_INVESTIGATOR
Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Rheumatology and Immunology, University Hospital Bern, Inselspital
Bern, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRAFT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.