Supplemental Screening for Breast Cancer With Abbreviated Breast MR for Black Women With Increased Breast Density
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Breast cancer detection and false negative rates of supplemental screening with AB-MR
研究概览
简要总结
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. African American 2. negative DBT examination 11 months prior to recruitment 3. Heterogeneously and Extremely breast densities 4. clinically asymptomatic- no palpable masses, focal thickening or clinically significant discharge. Investigators will identify these patients EPIC database utilizing the date of their last mammogram. Interested patients may contact our research coordinators by the phone number provided in the recruitment materials. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.
详细描述
500 patients will be prospectively recruited to undergo an abbreviated or "FAST" breast MRI examination. The women will be recruited for the study must meet the following criteria: 1. African American 2. negative DBT examination no more than 11 months prior to the FAST MR 3. Heterogeneously and Extremely breast densities as graded on their most recent mammogram 4. clinically asymptomatic- no palpable masses, focal thickening or clinically significant nipple discharge. Investigators will identify these women via the EPIC database utilizing the date of their last mammogram. Interested women may contact our research coordinators by the phone number provided in the recruitment materials. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •African American female
- •Negative DBT examination within eleven months prior to recruitment
- •Heterogeneoulsy and Extremely breast densities
- •Clinically asymptomatic- no palpable masses or focal thickening, etc.
排除标准
- •Patients who are pregnant and lactating
- •Patient who have not had a mammogram (DBT) in the past 11months
- •Patients who are unwilling or unable to provide written informed consent
- •Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, ect.)
- •Recent breast surgery in the past 2 years including breast enhancements (e.g. implants or injections)
- •Patients who are unable to received an MRI with Gadolinium contrast
- •Patients who have not had an MRI of the breast with the past year
结局指标
主要结局
Breast cancer detection and false negative rates of supplemental screening with AB-MR
时间窗: Through the completion of study, an average of 4 year
The cancer detection and false negative rate (per 1000 women screened) of supplemental screening with AB-MR in this population will be measured as well as the stage, grade and subtype of detected and non-detected breast cancers.
Additional screening outcomes
时间窗: Through the completion of study, an average of 4 year
The rates of false positive exams prompting biopsy and short term follow-up recommendations after AB-MR will be evaluated.
次要结局
- The screening outcomes of AB-MR in this population of Black women will be compared to a similar population of Caucasian women undergoing AB-MR.(Through the completion of study, an average of 4 year)