EUCTR2007-002888-27-DE进行中（未招募）不适用
Intra-individual, randomized comparison of the MRI contrast agents Gadovist® 1.0 versus Prohance® in patients with primary and secondary brain tumors, evaluated in a blinded read
Knappschaftskrankenhaus Bochum0 个研究点开始时间: 2008年7月8日最近更新:
相关药物
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
- •Patients (> 18 yrs) with known CNS lesion(s) indicated for contrast enhanced MRI for diagnosis and are scheduled for neurosurgical treatment
- •Patients who are willing to undergo study procedures
- •Patients who are willing and able to sign informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have previously entered this study
- •Patients who are or are suspected in pregnancy or nursery
- •Patients with any physical or mental status that interferes with the signing of informed consent
- •Patients with a contraindication for MRI
- •Patients who have received any contrast material in 12 hours prior to injection with study or comparator drug in combination with moderate or severe renal impairment.
- •Patients who require emergency treatment
- •Patients with severely impaired hepatic or renal functions (e.g. SGPT ? 2 times the upper limit of reference range, acute renal failure)
- •Patients with underlying disease or concomitant medication which may interfere with efficacy evaluation
- •Patients who are scheduled for CNS surgery or who would have a biopsy prior to the second planned injection of contrast medium
- •Patients with known anaphylactoid or anaphylactic reaction to any contrast media
研究者
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