A Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis

Giant Cell Arteritis Clinical Trial

— CRAFT  

Official title:

Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335888
• Other study ID #: CRAFT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: May 2029

Study information

• Verified date: April 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Britta Maurer
• Phone: +41 31 63 2 7229
• Email: RI-Studien[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica
• Vasculitis

Intervention

Drug:
• AzaFol
AzaFol-PET/CT imaging
• FDG
FDG-PET/CT imaging

Locations

Country	Name	City	State
Switzerland	Department of Rheumatology and Immunology, University Hospital Bern, Inselspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Paul Scherrer Institut, Center for Proton Therapy

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline
Secondary	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.	Baseline