Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Assess if pre-operative MRI reduces incidence of re-excisions required
研究概览
简要总结
This study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. The investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.
详细描述
This is a prospective pragmatic trial randomizing women diagnosed with early stage breast cancer to MRI versus no breast MRI. Data analyzed will include medical record information abstracted from the clinical records. Date and modality of all imaging performed, malignancy(s) identified, abnormalities identified, image guided procedures performed, surgical procedures performed and pathology results.
The primary aim of this study is to assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma.
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
- 否
入选标准
- •Must undergo definitive local therapy with either breast conserving therapy or mastectomy
- •Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative
- •Able to undergo breast MRI
排除标准
- •Not pregnant or breastfeeding
- •No prior breast MRI for the newly diagnosed carcinoma at the outside hospital
- •No prior mantle radiation
- •No locally advanced breast cancer
- •No diffuse malignant appearing microcalcifications requiring mastectomy
- •No known collagen vascular disease
- •No previous ipsilateral radiation
- •No participants who undergo surgery at an outside institution
- •No prior history of breast carcinoma
结局指标
主要结局
Assess if pre-operative MRI reduces incidence of re-excisions required
时间窗: 2 years
Assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma
次要结局
- Total Mastectomy Rates(2 years)
- Number of biopsies(2 years)
- Local-regional recurrence rates(2 years)
- Number of malignancies in contralateral breast(2 years)
- Time from diagnosis to local therapy(2 years)
研究者
Mehra Golshan, MD
Principal Investigator
Dana-Farber Cancer Institute