NCT00588614已完成不适用
High Risk Screening Breast MR Using a Rapid Imaging Exam
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The primary aim of the study is to estimate the negative predictive value (NPV) of the abbreviated exam for screening purposes, using a full length diagnostic study for confirmation and one year follow-up exams.
研究概览
简要总结
This study is being done to find out if breast cancer detection will be improved using a short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are at an increased risk of developing breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •High risk for the development of breast cancer. For the purposes of this study high risk women will be defined as those having one of the following:
- •One or more first degree blood relative(s), maternal or paternal, with known primary breast cancer, PLUS a Gail model calculated 5 year risk of greater than or equal to 1.67%
- •First, and/or second degree blood relative(s) with a family history suggestive of a BRCA mutation (those families having a member(s) with primary breast cancer diagnosed at or before the age of 40, primary breast cancer and ovarian cancer within the same family or family member, male relative with primary breast cancer, a relative with bilateral breast cancer, or multiple generations of family members with primary breast and/or ovarian cancer)
- •A known BRCA mutation
- •A family member carrying a known BRCA mutation
- •A personal history of a high risk breast lesion, including lobular carcinoma in situ and atypical hyperplasia
- •A personal history of primary breast cancer (invasive or in-situ) treated with unilateral mastectomy
- •Patients must have a mammogram performed within the last 6 months, and the mammography images must be available for review at the time of the MR interpretation.
排除标准
- •They are unable to return in one year for follow-up exam
- •Medical history includes:
- •Previous breast cancer treated with breast conservation
- •History of benign excisional biopsy in the previous 24 months
- •History of a benign core needle biopsy or FNA in the previous 12 months
- •History of metastatic cancer
- •45 minute prone scan cannot be tolerated
- •Pregnant, as a mammogram for correlation with MR is required
- •History of breast MR in the last 6 months
结局指标
主要结局
The primary aim of the study is to estimate the negative predictive value (NPV) of the abbreviated exam for screening purposes, using a full length diagnostic study for confirmation and one year follow-up exams.
时间窗: 2 years
次要结局
- Secondary aim is to estimate the proportion of patients who go on to have a more comprehensive exam based on the results of the short exam.(2 years)
研究者
研究点 (1)
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