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

NCT06335888 | Recruiting Phase 2 DMC

• 1 other identifier: CRAFT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Giant Cell Arteritis

Keywords

Tracer; PET imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Lesion detection rate (visual analysis)

  Baseline

• Lesion detection rate (semiquantitative analysis)

  Baseline

• Sensitivity of the GCA-diagnosis at the patient level

  Baseline

Study Arms (2)

AzaFol first, FDG second

EXPERIMENTAL

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

Drug: AzaFol; Drug: FDG

FDG first, AzaFol second

ACTIVE COMPARATOR

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

Drug: AzaFol; Drug: FDG

Interventions

AzaFol DRUG

AzaFol-PET/CT imaging

AzaFol first, FDG second; FDG first, AzaFol second

FDG DRUG

FDG-PET/CT imaging

AzaFol first, FDG second; FDG first, AzaFol second

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Paul Scherrer Institut, Center for Proton Therapy: collaborator
• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Rheumatology and Immunology, University Hospital Bern, Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Britta Maurer

  Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Britta Maurer

CONTACT

+41 31 63 2 7229; RI-Studien@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over, randomized, open label, single-centre

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)