ACTRN12608000455369已完成3 期
A multicenter, randomized, double-blind, crossover, phase 3 study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist 'Registered trade mark') in patients referred for contrast-enhanced Magnetic Resonance Imaging (MRI) of the central nervous system (CNS). Protocol number 310123
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 402
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Is referred for a contrast-enhanced MRI of the Central Nervous System based on current clinical symptoms or results of a previous imaging procedure.
- •Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and has consented to participate.
排除标准
- •Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents.
- •Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.
- •Has severe cardiovascular disease (eg, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours).
- •Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period.
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