EUCTR2007-004746-33-DE进行中（未招募）不适用
A multicenter, randomized, double-blind, crossover, phase 3 study to determine the safety and efficacy of gadobutrol 1.0 molar (Gadovist®) in patients referred for contrast-enhanced MRI of the central nervous system (CNS)
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
- 350
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
- •A patient who meets the following criteria will be eligible for enrollment into the study:
- •1.Is at least 18 years of age
- •2.Is referred for a contrast-enhanced MRI of the CNS based on current clinical symptoms or results of a previous imaging procedure
- •3.Is willing to undergo the routine contrast-enhanced MRI examinations with gadoteridol and with gadobutrol
- •4.Is willing and able to complete all study procedures specified in the protocol
- •5.Patient is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test within 1 hour prior to the administration of gadobutrol and gadoteridol
- •6.Has a glomerular filtration rate (GFR) value = 60 mL/min/1.73m2 derived from a serum creatinine result within 2 weeks prior to study enrollment
- •7.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
- •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
- •A patient who meets any of the following criteria may not participate in this study:
- •1.Is a female patient who is pregnant or nursing
- •2.Has received any investigational product or has participated in any other clinical trial within 30 days prior to enrolling in this study
- •3.Has been previously enrolled in this study or any other study using gadobutrol
- •4.Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents
- •5.Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
- •6.Has received any contrast agent within 24 hours prior to the study MRIs, or is scheduled to receive any contrast agent within 72 hours after the second study MRI
- •7.Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure)
- •8.Has severe cardiovascular disease (eg. known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)
- •9.Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period
- •10.Has any contraindication to gadoteridol according to the package insert
- •11.Is expected or is scheduled to have a change in any treatment or procedure between the gadoteridol and gadobutrol MRIs that may alter their interpretation
- •12.Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 72 hours after the second study MRI
研究者
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