EUCTR2005-004170-25-BE进行中（未招募）不适用
A PHASE III, MULTI-CENTER, OPEN-LABEL STUDY TO EVALUATE SAFETY AND EFFICACY OF MULTIHANCE® AT THE DOSE OF 0.10 mmol/kg IN MAGNETIC RESONANCE IMAGING OF THE CENTRAL NERVOUS SYSTEM IN PEDIATRIC PATIENTS. - MRI in Pediatric CNS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 188
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
- •All the patients aging between 2 and 17 years,which have known or highly suspected disease of the CNS (brain/spine) and are referred for cranial or spinal MR examination requiring an injection of MR contrast agent and give their consent (or have their parents' consent)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Are excluded from this study all the following patients: - Have any contraindications to an MR examination - Are undergoing the MR examination in an emergency situation; - Have any known allergy to one or more of the ingredients in the study contrast agents; or have a history of hypersensitivity to any metals or chelates of gadolinium; - Have received any other contrast medium, either intra-vascularly or orally, within the 48 hours before and up to 72 hours following the administration of the investigational product; - Are likely to undergo an invasive examination or intervention within72 hours after the administration of the investigational product; - Have received or have been scheduled to receive an investigational compound and/or medical device within 30 days prior to admission into this study or within 72 hours post-administration of the investigational product; - Are a female who is lactating or pregnant (for females who have started menses; the possibility of pregnancy must be excluded by serum or urine beta-HCG on-site within 24 hours prior to the investigational product administration); - Have sicle cell anemia
研究者
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