Cross-over, Randomized, Open-label, Single-centre, Phase II Clinical Trial to Investigate 18F-AzaFol in the Diagnosis of Large Vessel Vasculitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Specificity of the GCA-diagnosis at the patient level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
AzaFol first, FDG second
AzaFol PET/CT imaging followed by FDG PET/CT imaging (standard of care)
干预措施: AzaFol (Drug)
AzaFol first, FDG second
AzaFol PET/CT imaging followed by FDG PET/CT imaging (standard of care)
干预措施: FDG (Drug)
FDG first, AzaFol second
FDG PET/CT imaging (standard of care) imaging followed by AzaFol PET/CT
干预措施: AzaFol (Drug)
FDG first, AzaFol second
FDG PET/CT imaging (standard of care) imaging followed by AzaFol PET/CT
干预措施: FDG (Drug)
结局指标
主要结局
Specificity of the GCA-diagnosis at the patient level
时间窗: Baseline
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
次要结局
- Lesion detection rate (visual analysis)(Baseline)
- Lesion detection rate (semiquantitative analysis)(Baseline)
- Sensitivity of the GCA-diagnosis at the patient level(Baseline)