Breast MRI as a Preoperative Tool for DCIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 4
- 主要终点
- To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.
研究概览
简要总结
Breast MRI is a fairly new technology, but it has been well studied. It is now used routinely in many patients with breast cancer. It has been shown to be useful in detecting areas of cancer that cannot be seen using other types of scans or tests.
The purpose of this study is to see how often MRI can find other areas of cancer in women with one area of breast cancer, and to determine how having the MRI test affects their treatment. The purpose is also to study any areas of abnormality seen on your MRI with special methods that allow the images of your breast tissue and the microscopic analysis of your breast tissue to be compared very carefully. The study also aims to follow women who enter the study over a 10-year period to determine how often the breast cancer comes back.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age less than 60 at time of consent
- •Clinical stage is consistent with Stage 0 or Stage I T1mic at presentation
- •Core biopsy proven DCIS or DCIS with microinvasion (invasion ≤0.1 cm), prior to enrollment
- •Breast surgery to be performed at MSKCC
- •Informed consent obtained
排除标准
- •Age 60 or over at time of consent
- •Patients who are pregnant or nursing
- •Patients with contraindications to breast conservation
- •Excisional biopsy of DCIS or DCIS with microinvasion, prior to enrollment
- •Patients with any contraindications to MRI including pacemaker, tissue expander, other metallic surgical implants, weight over 350 lb., previous gadolinium reaction, metal fragments in eye
结局指标
主要结局
To prospectively evaluate the value of preoperative breast MRI in women with core biopsy-proven DCIS.
时间窗: conclusion of the study
次要结局
- To determine the proportion of all patients in this study in whom breast MRI identifies at least one site of cancer separate from the index lesion.(conclusion of the study)
- To estimate the proportion of patients with DCIS in which preoperative MRI will change surgical planning.(conclusion of the study)
- To estimate the long-term ipsilateral breast recurrence rate in women with DCIS undergoing preoperative breast MRI.(conclusion of the study)
- To estimate re-excision rates and mastectomy rates in patients with DCIS undergoing preoperative MRI.(conclusion of the study)