NCT01859936已完成4 期
Randomized Multicenter Trial Assessing if Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Will Change Primary Treatment
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Change of treatment plan
研究概览
简要总结
The study is a prospective randomised multicenter trial assessing the additional value of breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies? Will preoperative breast MRI be cost effective?
详细描述
Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women under 56 years of age
- •Newly diagnosed breast cancer
- •Swedish or English speaking
排除标准
- •Claustrophobia
- •Pregnancy
- •Renal failure
- •Metal items in patients
结局指标
主要结局
Change of treatment plan
时间窗: 14 days
Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan
次要结局
- Did breast magnetic resonance imaging reduce the number of reoperation during primary management(6 months)
- Did breast magnetic resonance imaging increase the number of mastectomies(6 months)
- Did breast magnetic resonance imaging affect cost(6 months)
研究者
Brita Arver
MD, PhD
Karolinska University Hospital
研究点 (2)
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