NCT00907530已完成4 期
Phase IV, Double-Blind, Multi-Center, Randomized, Crossover Study to Compare 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® in Magnetic Resonance Imaging (MRI) of the Brain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets).
研究概览
简要总结
This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enroll subjects in this study if they meet the following inclusion criteria:
- •Are at least 18 years of age or older
- •Are able to give written informed consent and are willing to comply with the protocol requirements
- •Are scheduled to undergo MRI
- •Are willing to undergo two MRI procedures within 14 days
- •Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
- •clinical/neurological symptomatology;
- •diagnostic testing, such as CT or previous MRI examinations; or
- •have had recent surgery within 6 months and are to be evaluated for recurrence.
排除标准
- •Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed.
- •Are pregnant or lactating females. Exclude the possibility of pregnancy:
- •by testing on site at the institution (serum or urine bHCG) within 24 h prior to the start of each investigational product administration
- •by history (i.e., tubal ligation or hysterectomy)
- •post menopausal with a minimum of 1 year without menses
- •Have any known allergy to one or more of the ingredients in the investigational product, or have a history of hypersensitivity to any metals
- •Have congestive heart failure (class IV according to the classification of the New York Heart Association
- •Have suffered a stroke within a year
- •Have received or are scheduled to receive any other contrast medium in the 24 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h following Exam 2
- •Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 h post-administration of the second investigational product.
- •Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 mL/min.
- •Have been previously entered into this study
- •Have received or are scheduled for one of the following:
- •Surgery within three weeks prior to the first examination or between the two examinations
- •Initiation of steroid therapy between the two examinations
- •Radiosurgery between the two examinations
- •Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field.
- •Are suffering from severe claustrophobia
- •Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
研究组 & 干预措施
GADOVIST
Active Comparator
gadobutrol
干预措施: GADOVIST (Drug)
结局指标
主要结局
To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets).
时间窗: Day 1 and Day 2
次要结局
未报告次要终点
研究者
研究点 (1)
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