[18F]fluor-PEG-folate PET/CT imaging in giant cell arteritis: a pilot study

Universitair Medisch Centrum Groningen2 sites in 1 country10 target enrollmentSeptember 11, 2024

Drugs31-(4-(((2-amino-4-oxo-3,4-dihydropteridin-6-yl)methyl)amino)-benzamido)-1-(4-fluorophenyl)-1,6,28-trioxo-9,12,15,18,21,24-hexaoxa-2,5,27-triazadotriacontan-32-oic acid [18F]Fluor-PEG-Folate

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Universitair Medisch Centrum Groningen
Enrollment: 10
Locations: 2
Primary Endpoint: Arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Primary Objective: to evaluate arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.

Registry

euclinicaltrials.eu

Start Date

September 11, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Universitair Medisch Centrum Groningen

Responsible Party

Principal Investigator

K.S.M. van der Geest

Scientific

Universitair Medisch Centrum Groningen

Eligibility Criteria

Inclusion Criteria

•Age ≥ 50 years at time of disease onset - Erythrocyte sedimentation rate (ESR) ≥50 mm/hr or C-reactive protein (CRP) ≥ 10 mg/L - Clinical symptoms of large vessel GCA (at least one of the following) at time of inclusion: constitutional symptoms (fatigue, fever, weight loss, and/or night sweats), limb claudication, or symptoms of polymyalgia rheumatica (i.e. shoulder and/or hip girdle pain associated with morning stiffness). - Imaging findings consistent with large vessel GCA at the time of inclusion (e.g. ultrasound, FDG-PET/CT) - Patients must be able to adhere to the study appointments and other protocol requirements. - Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.

Exclusion Criteria

•Clinical symptoms suggestive of cranial GCA (at least one of the following): new-onset localized headache, scalp tenderness, temporal artery abnormality (thickening, tenderness, and/or decreased pulsation), ischemia-related vision loss, stroke, transients ischemic attack, jaw or tongue claudication (pain upon mastication). - Ultrasound findings consistent with cranial GCA (e.g. halo sign in temporal or facial artery). - A prior positive temporal artery biopsy. - Initiation or dose escalation of systemic glucocorticoid therapy (oral, IM, IV) in the 4 weeks prior to inclusion - Initiation or dose escalation of disease-modifying antirheumatic drugs (DMARDs) within 3 months prior to inclusion - Treatment with any investigational drug within 3 months prior to inclusion. - Females with child bearing potential. Post-menopausal women with >12 months of amenorrhoea are considered to have no child bearing potential. Given the age distribution of patients with GCA, exclusion of females with child bearing potential will not lead to recruitment bias in the study. - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion.

Outcomes

Primary Outcomes

Arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.