Brazilian Randomized Study - Impact of Preoperative Magnetic Resonance in the Evaluation for Breast Cancer Conservative Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- False positive rate, false negative rate, positive predictive value and negative predictive value MRI in the Breast Cancer conservative surgery
研究概览
简要总结
The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I, II and III candidates for conservative surgery will be randomly randomized to do MRI or not according mammary density.
详细描述
The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer.An accurate assessment of the tumor is essential to select the best therapeutic strategy in the treatment of breast cancer.Currently, mammography, ultrasound and clinical examination are the standard techniques to assess the extent and location of the tumor.However, these imaging methods fail to assess the real size in approximately one third of patients eligible to conservative treatment.MRI has high sensitivity (95-100%) in the detection of invasive cancers as well as being able to detect hidden tumors, multifocality, multicentricity and cancer in the contralateral breast more often and greater accuracy than mammography or ultrasound.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years with breast cancer
- •Clinical stages I, II and III candidates for conservative surgery
排除标准
- •Contra-indication for breast MRI (ex. Metal implant)
- •Claustrophobia
- •Impossibility to stay in the prone position for more than an hour
- •History of allergic reaction to the paramagnetic contrast
- •History of chronic kidney disease on dialysis
- •Personal history of breast cancer treated surgically in the last 12 months.
- •Pregnancy or breastfeeding past 6 months
结局指标
主要结局
False positive rate, false negative rate, positive predictive value and negative predictive value MRI in the Breast Cancer conservative surgery
时间窗: 3 years
次要结局
- Describe the percentage of positive margins on pathological examination(3 years)
- Describe the percentage surgical change from conservative surgery to mastectomy(3 years)
- Calculate the False positive rate, false negative rate , positive predictive value and negative predictive value according mammographic density, molecular subtype and histopathology of the tumor(3 years)
- Calculate the period after successful treatment in which there is no appearance of the symptoms or effects of the disease after 3 and 5 years bettwen groups(5 years)
- Calculate how much is the cost to do the exam considering the false positive and false negative rates(3 years)
- Describe the percentage of additional surgery rates(3 years)