Development and Testing of an Accurate, Rapid and Inexpensive MRI Protocol for Breast Cancer Screening - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- True Positive
研究概览
简要总结
The purpose of this study is to test an innovative MRI breast cancer screening method in women with mammographically dense breasts as well as other women with moderately increased cancer risk. MRI, combined with other methods of risk assessment, has potential to significantly improve sensitivity to cancer in dense breasts and detect cancer in all cases at a much earlier stage, with far fewer interval cancers than mammography. Previous tests of MRI sensitivity show that this screening could significantly increase the likelihood of detecting invasive cancers resulting in decreased mortality from breast cancer.
Suspicious lesions will be defined by the clinical interpretation of the breast MRI images performed by the attending breast radiologists. Based on the radiologist determination that the MRI findings are suspicious (these findings include masses, non-mass enhancement and foci), suspicious lesions will be assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0, 4 and 5. False positive diagnosis should be minimized as all attending physicians reading breast MRI at this institution are fellowship trained in breast imaging.
详细描述
- BACKGROUND X-ray mammography has significantly reduced breast cancer mortality, yet many cancers are still detected at advanced stages. Early detection remains the best approach for improving outcomes. MRI offers high sensitivity and can detect cancers-especially aggressive subtypes and those in dense breasts-years earlier than mammography. In areas like south Chicago, with disproportionately high rates of aggressive breast cancer, MRI screening could dramatically reduce morbidity and mortality if implemented effectively.
Mammography is less effective for women with dense breasts and does not always detect cancer until tumors are relatively large. Women with dense breasts or those at increased risk for aggressive cancers (e.g., triple-negative) often lack adequate screening options. MRI has consistently shown superior sensitivity, and its performance is not diminished by breast density. Concerns remain, however, about MRI's specificity, potential false positives, and perceived cost for general screening. Nevertheless, newer techniques and protocols may mitigate these limitations.
Routine mammography improves survival by detecting cancers early, but sensitivity can be reduced by 30-50% in dense breasts. Since these women are also at higher risk for aggressive cancers, better screening tools are needed. Earlier detection with MRI could significantly decrease both morbidity and mortality.
________________________________________ 2. PURPOSE / HYPOTHESIS We propose a novel MRI-based breast cancer screening protocol for women with dense breasts and/or moderately increased risk. Our goal is to establish a fast, quantitative, and cost-effective MRI exam that enhances sensitivity while maintaining acceptable specificity and feasibility for clinical use.
Prior data suggest MRI screening may improve early detection of invasive cancers and reduce interval cancers [1,8,9]. The University of Chicago is uniquely positioned to lead this effort, particularly in underserved areas with high breast cancer burden.
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women that have had a mammographically and/or sonographically identified finding that will require image guided biopsy
- •Women between ages 40-74 with dense breasts having a mammogram
- •Women identified as having an average or intermediate risk of breast cancer (defined as 10- 20% lifetime risk based on a clinical risk model).
排除标准
- •Women with metallic implants
- •Women that are claustrophobic
- •Women that have a fear of needles or contrast
- •Women that have had an allergic reaction to contrast in the past
- •Women that are pregnant
- •Women who are demonstrated to be at risk for an allergic reaction or nephrogenic systemic fibrosis (NSF)
结局指标
主要结局
True Positive
时间窗: 30 days
The number of abbreviated scans that successfully determines a cancer, confirmed by biopsy, based on the radiologist determination that the MRI findings are suspicious. Suspicious lesions were assigned a Bi-Rads code specifying whether additional work up or biopsy is necessary. These are Bi-Rads codes 0 (incomplete - need additional imaging evaluation), 4 (suspicious for malignancy - biopsy should be considered) and 5 (highly suggestive of malignancy - appropriate action should be taken).
次要结局
- True Negative(30 days)