EUCTR2010-023003-96-DE进行中（未招募）不适用
Open-label, multicenter, pharmacokinetic, and safety study in children (term newborn infants to 23 months of age) undergoing a contrast-enhanced MRI with an intravenous injection of 0.1 mmol/kg BW gadobutrol 1.0 M (Gadovist 1.0)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced MRI of any body region
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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
- •- Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after gadobutrol injection
- •- Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture)
- •- Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation
- •- Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection
- •- Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
- •- History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
- •- Subject with renal insufficiency of any intensity, i.e. eGFR <80% of age adjusted normal value calculated based on the Schwartz formula
研究者
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