NCT00486473已完成3 期
Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Sensitivity in diagnosing breast lesions compared to histopathology results
研究概览
简要总结
To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Provides written informed consent
- •Age 18 years or older
- •Suspicious or known breast lesion based on results from mammography or ultrasound
- •Planned to undergo histological diagnosis of breast lesion by having a non surgical biopsy or breast surgery within 30 days after the MRI exam
排除标准
- •Body weight > 100 kg
- •Pregnant or lactating
- •Server or end-stage organ failure
- •Moderate to severe renal impairment
- •Undergoing radiotherapy or completed radiotherapy in the last 18 months
- •Chemotherapy within 6 months of the 1st MRI exam
结局指标
主要结局
Sensitivity in diagnosing breast lesions compared to histopathology results
时间窗: up to 6 months
次要结局
- Sensitivity, specificity, accuracy, PPV and NPV at region, breast and patient levels(up to 6 months)
研究者
研究点 (1)
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