A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Recruiting
Phase 2Interventional Study
Giant Cell Arteritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
70 (estimated)
Sponsor
Insel Gruppe AG, University Hospital Bern · Other
Who this trial is looking for
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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.
Trial Locations
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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 info…
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.
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