A Phase IV Double-blind Multicenter Randomized Crossover Study to Compare 0.10 mmol/kg of Multihance With 0.10 mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Global Diagnostic Preference Between the Two Exams
研究概览
简要总结
Compare the efficacy of MultiHance and Magnevist
详细描述
The purpose of this study was to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Was 18 years or older
- •Provided written informed consent
- •Scheduled for MRI
- •Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days
排除标准
- •Pregnant or lactating females
- •Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
- •Congestive heart failure, class IV
- •Previous stroke in the past year
- •Received another contrast agent within 24 hours pre and post each exam
- •Investigational product
- •Contraindications to MRI
- •Severe claustrophobia
- •Surgery with 3 weeks prior
- •Steroid therapy or radiosurgery between two exams
研究组 & 干预措施
MultiHance
0.5 M MultiHance at a single injection
干预措施: Multihance (Drug)
Magnevist
0.5 M Magnevist at a single injection
干预措施: Arm 2 - Magnevist (Drug)
结局指标
主要结局
Global Diagnostic Preference Between the Two Exams
时间窗: Postdose Images for MultiHance Exam and for Magnevist Exam Compared
Assessed by 3 blinded Readers for each of the 41 patients who had both MultiHance and Magnevist post dose MRI exam to assess whether the image with MultiHance was preferred, both contrast agents were equal, or the image with Magnevist was preferred. Each patient's image was reviewed by 3 readers.
次要结局
- Lesion Contrast Enhancement Between the Two Exams(Postdose Images for MultiHance Exam and for Magnevist Exam Compared)
- Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 1(Predose and immediately postdose)
- Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 2(Predose and immediately postdose)
- Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 1(Predose and immediately postdose)
- Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 3(Predose and immediately postdose)
- Lesion-to-brain Ratio (LBR) for Each Lesion - Reader 3(Predose and immediately postdose)
- Lesion Border Delineation(Postdose Images for MultiHance Exam and for Magnevist Exam Compared)
- Contrast-to-noise Ratio (CNR) for Each Lesion - Reader 2(Predose and immediately postdose)
- Percentage of Lesion Contrast Enhancement (LCE) - Reader 1(Postdose)
- Percentage of Contrast Enhancement of the Lesion - Reader 2(Postdose)
- Percentage of Contrast Enhancement of the Lesion - Reader 3(Postdose)