Non-contrast DWI for Supplemental Screening of Women With Dense Breasts
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 269
- 试验地点
- 4
- 主要终点
- Diffusion sensitization (b value)
研究概览
简要总结
Diffusion-weighted imaging (DWI) is a short (under 5 minutes) non-contrast MRI technique that has shown promise for the detection and characterization of breast cancer. Our preliminary data has shown that DWI holds potential for detecting mammographically and clinically-occult breast cancers. However, current technical limitations reduce the sensitivity of DWI for screening applications.
The identification of a screening tool to complement mammography that is more accurate than ultrasound and faster, less expensive, and safer than conventional contrast-enhanced MRI would have significant clinical impact by improving the early detection of cancer in women with dense breasts. We hypothesize that an optimized DWI approach will enable detection of mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.
详细描述
Hypothesis: With technical optimizations, non-contrast DWI can detect clinically and mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.
Aim 1: Improve the breast DWI technique to maximize spatial resolution, reduce distortion, and increase lesion contrast.
- Develop novel DWI acquisition to increase spatial resolution and reduce distortion (using reduced field of-view and/or multishot echo planar imaging techniques)
- Identify optimal diffusion sensitization (b-value) to maximize conspicuity of cancers in women with dense breasts
Aim 2: Develop interpretation tools to optimize diagnostic performance for detecting cancer on DWI.
- Determine quantitative DWI thresholds (contrast-to-noise ratio, apparent diffusion coefficient [ADC]) that best differentiate benign and malignant lesions (i.e. maximize sensitivity and specificity)
- Develop computer aided assessment tools to facilitate clinical implementation and optimize reader accuracy
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 or older
- •Dense breast identified on mammogram
排除标准
- •Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR<60, contrast allergy, incompatible metal)
- •Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
- •Women who are pregnant
结局指标
主要结局
Diffusion sensitization (b value)
时间窗: 2.5 years
Identify optimal b value to maximize conspicuity of cancers in women with dense breasts
Reader Interpretation strategy
时间窗: 3.5 years
Identify optimal ADC thresholds to differentiate malignant from benign lesions
Specificity
时间窗: 4.5 years
Specificity will be assessed for non-contrast DWI
Sensitivity
时间窗: 4.5 years
Sensitivity will be assessed for non-contrast DWI
次要结局
未报告次要终点