Macrophage imaging GCA

Phase 2

Recruiting

• Conditions: giant cell arteritis

• Registration Number: 2024-514491-40-00
• Lead Sponsor: Universitair Medisch Centrum Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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.

Trial Locations

Locations (2)

Amsterdam University Medical Center, VUmc Boelelaan; 🇳🇱 Amsterdam, Netherlands

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Amsterdam University Medical Center, VUmc Boelelaan

🇳🇱Amsterdam, Netherlands

Conny van der Laken

Site contact

31204444444

j.vanderlaken@amsterdamumc.nl