EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 4
- 主要终点
- Breast Imaging-Reporting And Data System (BI-RADS) scale
研究概览
简要总结
Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.
The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5)
- •Patient over 18 years old
- •Signed informed consent
排除标准
- •Patients at high risk of breast cancer, mutations BRCA 1 (BReast CAncer gene 1) or BRCA 2 (BReast CAncer gene 2) carriers, Li Fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation.
- •Patient unable to give informed consent for physical, mental, or legal reasons.
- •Patient not affiliated with French Social Security Insurance.
- •Patient under treatment for breast cancer.
- •When mammography is not recommended according to good practice by the French Health Authority (HAS).
- •Pregnant patient.
研究组 & 干预措施
standard mammography
standard mammography
干预措施: Standard mammography (Device)
standard mammography and tomosynthesis
standard mammography and tomosynthesis
干预措施: Standard mammography and tomosynthesis (Device)
结局指标
主要结局
Breast Imaging-Reporting And Data System (BI-RADS) scale
时间窗: Day 1
The primary evaluation parameter will be the classification error of tumors according to the BiRads scale obtained by mammography (BiRadsM) and by tomosynthesis (BiRadsT) according to the gold standard.
次要结局
- Total radiation dose(Day 30)
- Cost of the diagnostic strategies(Day 30)
- The number of ultrasound exams(Day 30)
- Number of additional examinations(Day 30)
- Criteria for a poor prognosis(Day 1)
- Agreement between readers(Day 1)
- Cumulative incidence of Breast cancer diagnosis(Month 24)