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Recruiting NCT06335888

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

Phase II Interventional Giant Cell Arteritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AzaFol, FDG.
Who it may be relevant to
Registry conditions: Giant Cell Arteritis. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Specificity of the GCA-diagnosis at the patient level [Time frame: Baseline]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Diagnostic

Study locations

Switzerland · 1 center
  • Department of Rheumatology and Immunology, University Hospital Bern, Inselspital — Bern

Identifiers

NCT: NCT06335888 · CRAFT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗