RecruitingPhase 2NCT06335888

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

Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

70 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

Giant Cell Arteritis

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

Min Age: 50 Years

Inclusion Criteria4

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 Criteria13

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)
Unable not to eat or drink (except water) for 6 hours prior to 2-\[18F\]FDG tracer application
Prior PET-imaging within 60 days before baseline
Intake of vitamin supplements containing > 1mg/day folic acid within 48 h prior to the PET/CT with AzaFol
Known hypersensitivity or allergy to folic acid
Enrolment of the investigator, his/her family members, employees and other dependent persons
Participation in another study with investigational drug within the 7 days preceding and during the present study.