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Taking peoplePhase 2

AzaFol scan to help diagnose giant cell arteritis

Tests an AzaFol scan for diagnosing giant cell arteritis in people with suspected disease.

Key facts

Who runs it
Insel Gruppe AG, University Hospital Bern
Where
Switzerland1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Status
Recruiting
Phase
Phase 2
People taking part
70 people, planned
Started
3 Feb 2025
Expected to end
May 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • AzaFol
  • FDG
Record updated
1 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 50 or older whose doctors suspect giant cell arteritis (GCA), a swelling of large blood vessels. Participants get two PET/CT scans, one with AzaFol and one with FDG.

Age
50 years and older
Sex
All sexes
Disease stage
Clinical suspicion of giant cell arteritis (GCA)
Earlier treatment
People cannot join if they had PET imaging within 60 days before the start. They also cannot be taking methotrexate, pemetrexed or raltitrexed.
Biomarker or test result
Women who can become pregnant must not have a positive blood pregnancy test at screening.

Main reasons for not taking part

  • Low folate (folic acid) levels, or allergy to folic acid
  • Pregnant, breastfeeding, or planning pregnancy during the study or within 30 days after the last dose
  • Glucose level > 10 mmol/l (180 mg/dL) at the time of the FDG scan
  • Unable to lie still for the scan (45 min) or to fast for 6 hours before it
  • Vitamins with > 1mg/day folic acid within 48 h before the AzaFol scan

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • 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
  • Participation in another study with investigational drug within the 7 days preceding and during the present study
  • Known hypersensitivity or allergy to folic acid
  • 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
  • Folate deficiency
  • 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)
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

Participants will undergo AzaFol-PET/CT imaging at a single timepoint.

The 2 groups in the trial

  • AzaFol first, FDG secondTreatment being tested

    AzaFol PET/CT imaging followed by FDG PET/CT imaging (standard of care)

    Treatment: AzaFol and FDG

  • FDG first, AzaFol secondExisting treatment, for comparison

    FDG PET/CT imaging (standard of care) imaging followed by AzaFol PET/CT

    Treatment: AzaFol and FDG

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
Plain-language title
AzaFol scan to help diagnose giant cell arteritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
1 May 2026