Imaging of inflamed arteries in giant cell arteritis with a PET/CT scan.
- Conditions
- giant cell arteritisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2020-001019-26-NL
- Lead Sponsor
- niversity Medical Center Groningen, Department of Rheumatology and Clinical Immunology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10
-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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
-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 Secondary Objective: -Assessment of the relationship between the [18F]fluor-PEG-folate uptake after 9 months of treatment and clinical disease activity at that time point. <br><br>-Assessment of the relationship between the [18F]fluor-PEG-folate uptake after 9 months of treatment and the development of relapses during the first 9 months of treatment. <br>;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 4 years;Main Objective: 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.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -The relationship between the [18F]fluor-PEG-folate uptake after 9 months of treatment and clinical disease activity at that time point. <br><br>-The relationship between the [18F]fluor-PEG-folate uptake after 9 months of treatment and the development of relapses during the first 9 months of treatment. ;Timepoint(s) of evaluation of this end point: 4 years