Improving Surveillance of Women With Personal History of Breast Cancer Using Contrast-Enhanced Mammography (CEM)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,647
- 试验地点
- 3
- 主要终点
- Cancer Detection
研究概览
简要总结
This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.
详细描述
The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population. Participants will be invited to three rounds of annual screening with CEM. CEM must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.
排除标准
- •Women with a history of prior iodinated contrast reaction
- •Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions)
- •Women who have had bilateral mastectomy
- •Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 30 mL/min
- •Pregnancy or lactation
- •Women actively being treated for cancer of any type with chemotherapy
- •Lump or other breast symptoms
- •Abnormality on prior breast imaging that is being followed.
研究组 & 干预措施
Contrast-enhanced mammogram
All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists
干预措施: Contrast-enhanced mammogram (Device)
结局指标
主要结局
Cancer Detection
时间窗: 48 months
Number of participants with cancer detected with contrast-enhanced mammography compared to tomosynthesis. Number of patients recalled for additional testing by each imaging test who do not have cancer (false positives). Outcomes will be assessed for both prevalence and incidence screens.
次要结局
- Reader Validation(48 months)
研究者
Wendie Berg
Professor of Radiology
University of Pittsburgh