A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Apparent Diffusion Coefficient (ADC)
研究概览
简要总结
A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.
详细描述
For this study, the investigators plan to evaluate DWI scans performed in women with breast lesions identified by conventional breast MRI. The investigators will determine whether an ADC threshold can be defined for distinguishing benign and malignant lesions on DWI, assess the difference in ADC cutoffs for mass and non-mass lesions, and investigate the potential improvement in accuracy using techniques such as nonzero minimum b-value (to remove perfusion effects in the ADC measures) and normalized ADC measures (to account for variations in water content and other factors).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Willing and able to provide written informed consent;
- •18 years of age or older;
- •Successful completion of breast MR examination with DWI required by protocol;
- •Undiagnosed breast lesion (BI-RADS 3, 4, or 5) identified on MRI. The BI-RADS assessment must refer to a focal finding within the breast (i.e. mass, non-mass, or focus) as opposed to diffuse processes (e.g. background parenchymal enhancement, skin thickening) or lesions outside the subcutaneous breast (e.g. axillary lymph nodes, focal skin lesions, osseous lesions, etc.).
排除标准
- •Participants with current or recent history (within 6 months prior to the MRI) of chemotherapy for cancer;
- •Neoadjuvant chemotherapy between MRI and confirmation of lesion outcome (study lesions must be biopsied prior to undergoing any chemotherapy);
- •Pregnant (if a female is of childbearing potential - defined as a pre-menopausal female capable of becoming pregnant - confirmation of pregnancy status per the site's standard of practice should be done prior to MRI);
- •Unwilling or not suitable to undergo MRI or use the contrast agent gadolinium.
研究组 & 干预措施
DCE-MRI and DWI
Single arm study, diagnosis defined as BIRADS 3, 4, or 5 lesion(s) based on DCE-MRI only with DWI collected in tandem as standard practice.
干预措施: DCE-MRI and DWI (Procedure)
结局指标
主要结局
Apparent Diffusion Coefficient (ADC)
时间窗: 1 year
Whether the Apparent Diffusion Coefficient (ADC), when used systematically in conjunction with conventional Dynamic Contrast Enhanced-Magnetic Resonance Imaging (DCE-MRI), can reduce the biopsy rate by at least 20% while maintaining sensitivity.
次要结局
- Local and Central Review Comparison (ADC Value Differences)(1 year)
- Minimum B-Value for Differentiating Lesions(1 year)
- Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC)(1 year)
- Optimal ADC Cutoffs by Lesion Type(1 year)
- ADC Measurements/Ratios to Define Subject Lesion Variations(1 year)