NCT05667532招募中不适用
The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography
研究概览
简要总结
To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared to standard mammography, can better detect breast cancers in women with dense breasts
详细描述
Primary Objectives:
- To establish a cohort of 1,000 female MDACC patients with dense breasts who undergo screening contrast-enhanced mammography.
- To establish a comprehensive integrated database of imaging, clinical data, health measurements, and questionnaire data including data from the companion protocol PA17-0584.
Secondary Objectives:
- To perform within-subject comparison of the cancer detection rate between CEM and FFDM.
- To perform within-subject comparison of the sensitivity, specificity, and recall rates of CEM compared to low-energy (LE) images (FFDM equivalent) and compared to a combination of LE and DBT images among women with dense breasts.
- To evaluate the effect of the availability of prior imaging for comparison on the recall rates of CEM, FFDM and DBT.
- In patients who undergo screening breast ultrasound as a standard of care, to evaluate the performance of screening ultrasound for breast cancer detection and compare it with other imaging modalities of CEM, LE images, and DBT.
Exploratory Objectives:
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and D) who undergo routine yearly mammography at participating MDACC sites
- •Willingness to co-enroll or currently enrolled in PA17-0584
- •Willingness to participate in the study and ability to provide informed consent
排除标准
- •Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.
- •Current or recent (within the prior 6 months) history of pregnancy or breast feeding
- •Personal history of breast cancer (DCIS or invasive breast cancer)
- •Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer
- •Breast biopsy within 6 months
- •Breast surgery within 12 months
- •Breast MRI, MBI, or CEM performed within 24 months
- •Known allergy to iodine-containing contrast agents
- •History of anaphylactic reaction to any substance that required hospitalization or IV placement in a patient with no known prior uneventful exposure to iodine-based IV contrast
- •Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)
研究组 & 干预措施
Contrast Enhanced Mammography
Experimental
干预措施: Contrast Enhanced Mammography (Diagnostic Test)
结局指标
主要结局
To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography
时间窗: through study completion; an average of 1 year.
次要结局
未报告次要终点
研究者
研究点 (1)
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