NCT00107484已完成2 期
Phase II Study of Combidex in Axillary Node Staging in Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) using ferumoxtran-10, may help find and diagnose breast cancer that may have spread to the axillary lymph nodes and may help in planning breast cancer treatment.
PURPOSE: This phase II trial is studying how well MRI using ferumoxtran-10 works in finding metastases to the axillary lymph nodes in patients with invasive breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the utility of magnetic resonance (MR) imaging using ferumoxtran-10 in identifying metastases to the axillary lymph nodes in patients with invasive breast cancer.
Secondary
- Determine the changes in MR T1 and T2 signal intensity in primary breast tumors after administration of this drug to these patients.
- Determine the potential of delayed imaging, in terms of defining tumor boundaries, in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes
时间窗: 2 years
次要结局
- Changes in MR T1 and T2 signal intensity(2 years)
研究者
研究点 (2)
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