Pilot Study of Dual-energy (DE) Contrast-enhanced (CE) Digital Mammography to Detect Breast Cancer in Patients With Increased Breast Density (Breast Imaging-Reporting And Data System (BI-RADS) Category c or d)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Percent Accuracy of Contrast Mammography
研究概览
简要总结
This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (BI-RADS category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer.
详细描述
This is a feasibility study to evaluate dual-energy (DE) contrast-enhanced (CE) digital mammography to detect breast cancer in patients with increased breast density (Breast Imaging-Reporting And Data System category c or d). Eligible patients will be invited to have full-field digital mammography and dual-energy (DE) contrast-enhanced (CE) digital mammography to compare accuracy of the imaging methods for the detection of breast cancer
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •At least 19 years old
- •Glomerular filtration rate> 60
- •Heterogeneously or extremely dense breasts (BI-RADS category c or d).
排除标准
- •History of iodinated contrast allergy
- •Pregnant or lactating as determined by routine standard practice
- •Personal history of breast cancer
- •History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)
- •History of prior breast reduction mammoplasty surgery
- •History of prior breast augmentation surgery
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
研究组 & 干预措施
Contrast enhanced mammography vs standard digital mammogram
Contrast-enhanced spectral mammography for the detection breast cancer .
干预措施: Dual-Energy Contrast-Enhanced (DECE) mammography (Device)
Contrast enhanced mammography vs standard digital mammogram
Contrast-enhanced spectral mammography for the detection breast cancer .
干预措施: digital mammography (Device)
结局指标
主要结局
Percent Accuracy of Contrast Mammography
时间窗: 1 year
•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).
Number of Participants With Cancer Detected
时间窗: 1 year
•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).
次要结局
- Number of Call Backs With Contrast Mammography(1 year)
研究者
Rachael Lancaster, MD
MD
University of Alabama at Birmingham