Giant Cell ArteritisPhase 2CRAFTNCT06335888
A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
A Phase 2 study testing AzaFol and FDG in people with Giant Cell Arteritis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- AzaFol and FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Feb 2025to May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, University Hospital Bern, Inselspital
Bern, 3010
Britta Maurer, Prof. Dr. med., +41 31 63 2 72 29, RI-Studien@insel.ch
About this study
Official title: Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
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.
Read the detailed description
Giant cell arteritis (GCA) is the most common systemic vasculitis in the elderly population. 2-[18F]Fluor-2-desoxy-D-glucose (2-[18F]FDG) positron emission tomography (PET)/ computed tomography (CT) is performed to diagnose GCA (standard of care, SOC) but unable to reliably distinguish atherosclerosis from vasculitis. Activated macrophages express folate receptor (FR)-β and are enriched in inflamed vascular tissue in GCA. 3'-Aza-2'-[18F]Fluoro-Folic Acid (AzaFol) is a nuclear tracer targeting FRβ. The investigators hypothesize that AzaFol is a specific and reliable tracer to visualize activated macrophages in GCA and therefore might improve the discrimination of vasculitic and atherosclerotic lesions as compared to 2-[18F]FDG-PET/CT.
- Conditions
- Giant Cell Arteritis
- Being tested
- AzaFol, FDG
- Keywords
- Tracer, PET imaging
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzaFolDrug
AzaFol-PET/CT imaging
FDGDrug
FDG-PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| AzaFol first, FDG second | Experimental | AzaFol PET/CT imaging followed by FDG PET/CT imaging (standard of care) Receives: Drug: AzaFol; Drug: FDG |
| FDG first, AzaFol second | Active comparator | FDG PET/CT imaging (standard of care) imaging followed by AzaFol PET/CT Receives: Drug: AzaFol; Drug: FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of the GCA-diagnosis at the patient level
Specificity of the GCA-diagnosis at the patient level using visual analysis as a diagnostic method with the clinical expert diagnosis as the reference standard
Measured: Baseline
Secondary outcomes (3)
Lesion detection rate (visual analysis)
Lesion detection rate in PET/CT in patients with suspicion of GCA, in patients with GCA (clinical expert diagnosis), and in patients without GCA (clinical expert diagnosis) by visual analysis at the level of the vessel.
Measured: Baseline
Lesion detection rate (semiquantitative analysis)
Lesion detection rate in PET/CT in patients with suspicion of GCA, in patients with GCA (clinical expert diagnosis), and in patients without GCA (clinical expert diagnosis) by semiquantitative analysis at the level of the vessel.
Measured: Baseline
Sensitivity of the GCA-diagnosis at the patient level
Sensitivity of the GCA-diagnosis at the patient level using visual evaluation as a diagnostic method with the clinical expert diagnosis as the reference standard.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start3 Feb 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cross-over, randomized, open label, single-centre
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Paul Scherrer Institut, Center for Proton Therapy
- Responsible party
- Sponsor
- Investigators
- Britta Maurer, Principal investigator, Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335888
- Sponsor's protocol ID
- CRAFT
- Acronym
- CRAFT
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
- ClinicalTrials.gov ID
- NCT06335888
- Acronym / sponsor ID
- CRAFT / CRAFT
- Conditions
- Giant Cell Arteritis
- Keywords
- Tracer, PET imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Paul Scherrer Institut, Center for Proton Therapy
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Giant cell arteritis (GCA) is the most common systemic vasculitis in the elderly population. 2-[18F]Fluor-2-desoxy-D-glucose (2-[18F]FDG) positron emission tomography (PET)/ computed tomography (CT) is performed to diagnose GCA (standard of care, SOC) but unable to reliably distinguish atherosclerosis from vasculitis. Activated macrophages express folate receptor (FR)-β and are enriched in inflamed vascular tissue in GCA. 3'-Aza-2'-[18F]Fluoro-Folic Acid (AzaFol) is a nuclear tracer targeting FRβ. The investigators hypothesize that AzaFol is a specific and reliable tracer to visualize activated macrophages in GCA and therefore might improve the discrimination of vasculitic and atherosclerotic lesions as compared to 2-[18F]FDG-PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-over, randomized, open label, single-centre
| Arm | Type | Receives |
|---|---|---|
| AzaFol first, FDG second | Experimental | Drug: AzaFol, Drug: FDGAzaFol PET/CT imaging followed by FDG PET/CT imaging (standard of care) |
| FDG first, AzaFol second | Active comparator | Drug: AzaFol, Drug: FDGFDG PET/CT imaging (standard of care) imaging followed by AzaFol PET/CT |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzaFolAzaFol-PET/CT imaging | Drug | AzaFol first, FDG second, FDG first, AzaFol second |
| FDGFDG-PET/CT imaging | Drug | AzaFol first, FDG second, FDG first, AzaFol second |
Primary outcome
Specificity of the GCA-diagnosis at the patient level
Time frame: Baseline
Specificity of the GCA-diagnosis at the patient level using visual analysis as a diagnostic method with the clinical expert diagnosis as the reference standard
3 secondary outcomes
Lesion detection rate (visual analysis)
Time frame: Baseline
Lesion detection rate (semiquantitative analysis)
Time frame: Baseline
Sensitivity of the GCA-diagnosis at the patient level
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Britta Maurer principal investigator
Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AzaFol and FDG in people with Giant Cell Arteritis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Britta Maurer (+41 31 63 2 7229, RI-Studien@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of the GCA-diagnosis at the patient level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.