New scan could spot hidden artery disease faster
NCT ID NCT06335888
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new type of PET/CT scan (AzaFol) to see if it can better diagnose giant cell arteritis, a condition that causes inflamed blood vessels. About 70 people with suspected GCA will get the new scan and a standard scan to compare accuracy. The goal is to improve diagnosis and reduce the need for invasive biopsies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Rheumatology and Immunology, University Hospital Bern, Inselspital
RECRUITINGBern, 3010, Switzerland
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