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New treatment option for Giant Cell Arteritis
Official title A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
ClinicalTrials.gov ID: NCT06335888
What this study is testing
What is AzaFol?
AzaFol is an investigational medicine, being studied as a potential treatment for giant cell arteritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Individuals ≥ 50 years with clinical suspicion of GCA
- Women of childbearing potential must not have a positive serum pregnancy test at the Screening Visit
- people must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent, approved by an...
- Are willing and able to comply with procedures required in this protocol.
You likely can't join if
- Folate deficiency
- Female people 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
See the full eligibility 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
- people 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...
- Are willing and able to comply with procedures required in this protocol.
- Folate deficiency
- Female people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.