A Clinical Trial to Investigate 18F-AzaFol in the Diagnos... | NCT06335888

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

NCT06335888

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Recruiting

Last Update Posted

May 1, 2026Actual

Enrollment

70Estimated

Phase

Phase 2

Conditions

Giant Cell Arteritis

Interventions

AzaFol
FDG

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2025Actual

Primary Completion Date

May 2029Estimated

Completion Date

May 2029Estimated

First Submitted Date

Mar 21, 2024

First Submission Date that Met QC Criteria

Mar 21, 2024

First Posted Date

Mar 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2026

Last Update Posted Date

May 1, 2026Actual

Name	Class
Paul Scherrer Institut, Center for Proton Therapy	OTHER

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
AzaFol	Drug	AzaFol-PET/CT imaging	AzaFol first, FDG second FDG first, AzaFol second

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Lesion detection rate (semiquantitative analysis)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Britta Maurer	Contact	+41 31 63 2 7229		RI-Studien@insel.ch

Overall Officials

Name	Affiliation	Role
Britta Maurer	Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Rheumatology and Immunology, University Hospital Bern, Inselspital	Recruiting	Bern		3010	Switzerland

ID	Term
D020293	Vasculitis, Central Nervous System
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D002561	Cerebrovascular Disorders