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

ConditionGiant Cell Arteritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • AzaFol

    Drug

    AzaFol-PET/CT imaging

  • FDG

    Drug

    FDG-PET/CT imaging

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: AzaFol first, FDG secondExperimental treatment 2 interventions
Group B: FDG first, AzaFol secondActive comparator 2 interventions

Trial outcomes

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

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Paul Scherrer Institut, Center for Proton Therapy

Collaborator

Source ClinicalTrials.gov
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