Use of Contrast Enhanced Spectral Mammography (CESM) for Women With Palpable Breast Abnormalities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- positive predictive value
研究概览
简要总结
Contrast Enhanced Spectral Mammography (CESM) is an advanced form of mammography which is performed after injection of contrast or dye into a vein in the arm. This dye is the same dye that is used for CT scans. This type of mammogram includes a regular mammogram as well as additional pictures with the dye.
This particular study is being done to determine if by adding the dye in the veins the investigators are better able to identify the cause of the lump than if they just did the regular mammogram alone.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women presenting for mammographic evaluation of an undiagnosed palpable mass found either by self examination and/or examination by referring physician
排除标准
- •Age < 25 years old
- •Male patients
- •Pregnant or lactating patients
- •Patients with allergy to iodinated contrast
- •Patients with a history of renal disease or patients over 70 with a creatinine > 1.
- •Creatinine must have been done within the last 12 weeks.
结局指标
主要结局
positive predictive value
时间窗: 1 year
(PPV) will be defined using three distinct definitions: (1) PPV1 is the proportion of women with a positive assessment who had a cancer diagnosis in the follow-up period. (2) PPV2 is the proportion of women with a recommendation for biopsy who had a cancer diagnosis in the follow-up period. (3) PPV3 is the proportion of women with a biopsy recommendation and a biopsy performed within 1 year who had a cancer diagnosis in the follow-up period. Negative predictive value (NPV) is the proportion of women with a negative assessment who did not have a cancer diagnosis.
次要结局
未报告次要终点