A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new imaging test called AzaFol-PET/CT to see if it can help doctors diagnose a condition known as Giant Cell Arteritis (GCA), which affects the large blood vessels. The study will compare this new test to another commonly used imaging test called 2-[18F]FDG-PET/CT and will also check if AzaFol is safe for patients. The trial is currently recruiting participants who are at least 50 years old and have symptoms that suggest they might have GCA.

If you qualify and decide to participate, you will have a single imaging test using AzaFol-PET/CT. It’s important to note that women who are pregnant or breastfeeding cannot join the study, and there are some other health criteria that must be met. Participants will need to follow specific instructions before the imaging, such as not eating or drinking anything except water for six hours prior to the test. This trial aims to find better ways to diagnose GCA, which can help doctors provide the best care for patients.

Gender

ALL

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.