NL-OMON52861尚未招募2 期
[18F]fluor-PEG-folate PET/CT imaging in Giant Cell Arteritis. - Macrophage imaging GCA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Age >= 50 years.
- •-ESR >=50 mm/hr (by Westergren method) or CRP >= 24.5 mg/L.
- •-Clinical symptoms of GCA (at least one of the following): unequivocal cranial
- •symptoms of GCA, symptoms of polymyalgia rheumatica or constitutional symptoms.
- •-Imaging findings consistent with GCA (at least by one of the following
- •methods): ultrasound, FDG-PET/CT, MRA or CTA.
- •-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.
排除标准
- •- 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
- •- 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
- •- Research-related radiation exposure (cumulative >=5 mSv) in the year
- •before inclusion.
研究者
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