EUCTR2014-002547-17-NL进行中(未招募)不适用
Grey matter microglial imaging with [18F]DPA-714 in progressive MS patients - [18F]DPA-714 PET in MS
VU University Medical Center0 个研究点开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- For the MS patient group: diagnosis primary or secondary progressive MS with EDSS scores 4.0 to 7.5 - 18 to 60 years
- •- Written informed consent
- •- No immunomodulating or immunosuppressive treatment in previous three months
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Inability to undergo MRI, e.g. metal objects in or around the body, claustrophobia or inability to lie still in the scanner. For the MS patients: contra-indication for gadolinium administration, e.g. previous allergic reaction to gadolinium.
- •- Homozygote Ala(147)Thr genotype (low-affinity binders)
- •- Significant immune disease other than MS
- •- (History of) other relevant neurological disease
- •- History of malignancy
- •- Known significant cardiac disease
- •- Inadequate renal function: creatinine clearance <60 ml/min
- •- Loss or donation of blood over 500 mL within four months prior to screening.
- •- In male subjects Hb < 8.0 g/dL, in female subjects Hb < 7.0 g/dL
- •- Pregnant or breast feeding
- •- (History of) alcohol and/or drug abuse
- •- Exposure to previous radiation leading to annual cumulative dose of more than 10 mSV if participating in this protocol
- •- Use of benzodiazepines within 1 week of the PET scan
研究者
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