Comparison of the Performance of Diagnostic Contrast-enhanced Mammography and Magnetic Resonance Imaging for Suspicious Breast Lesion At Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Diagnostic value for breast cancer
研究概览
简要总结
The main objective of this study is to compare the diagnostic performance of two diagnostic methods, namely CESM and MRI, in the evaluation of a lesion suspicious of breast cancer in 300 Quebec women referred for the investigation of breast cancer. breast lesion suspected of cancer. All suspicious lesions will be evaluated by these two diagnostic imaging and by TNM. Then, radiologists will respectively interpret diagnostic imaging, without knowing the result of the other imaging in parallel with the study. The sensitivity, specificity, positive predictive value and negative predictive value for his diagnostic imaging will then be determined. Histopathological confirmation by biopsy or surgery will be used as a standard value.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged 18 and over
- •At least one breast lesion with BIRADS classification 5
排除标准
- •Refusal to perform the biopsy or surgery
- •Pregnant or possibly pregnant woman
- •Usual contraindication to contrast product
- •Significant kidney failure
- •Allergy to contrast medium
- •hyperthyroidism
- •Usual contraindications to MRI
结局指标
主要结局
Diagnostic value for breast cancer
时间窗: Breast cancer screening
To measure sensitivity, specificity, positive predictive value and negative predictive value for CESM and MRI using histopathological confirmation as a standard value.
Diagnostic value for suspicious breast lesion
时间窗: Breast cancer screening
To determine the ability of diagnostic imaging to identify other breast masses suspicious of cancer.
次要结局
未报告次要终点