Value of Tomosynthesis in Breast Lesion Characterization and Breast Cancer Staging
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 424
- 试验地点
- 12
- 主要终点
- diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.
研究概览
简要总结
Study Rationale: an accurate breast cancer staging has a great impact in the management of a breast cancer. MRI is considered as the most sensible exam for this staging. However it has a low specificity and it may result in extra testing and stress for the patient, add to costs, and delay treatment. By contrast, Tomosynthesis is performed during the same time than mammography and has a good specificity. Although this modality is very promising, it has not been assessed in a population of consecutive patients.
Study objectives: To compare the diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at least 40 years old
- •Subject with a new lesion recommended for biopsy, whatever the modality which detected the lesion (clinical examination, mammography, tomosynthesis, US, or MRI)
排除标准
- •Subjects with BRCA mutation or at high genetic risk
- •Subjects who have breast implants
- •Personal history of breast cancer
- •Subjects who are pregnant or who think they may be pregnant
- •Subjects who are breast-feeding
- •Subjects who are unable or unwilling to tolerate study constraints
- •Subjects unable or unwilling to undergo informed consent
- •Subject with no rights from the national health insurance programme
结局指标
主要结局
diagnostic performance of preoperative bilateral Combo mode (MG+Tomosynthesis) versus mammography among women with breast cancer for the detection of additional multifocal, multicentric, and contralateral cancers.
时间窗: 1 year
In all sites, Mammography and Tomosynthesis will be standardised and performed according to the Combo mode with 2 views for each breast. Any additional breast lesion assigned a BI-RAD 4 or 5 score after the full staging work-up will be biopsied under the best imaging method. (BIRADS scale : BIRADS 4a or higher is considered to be positive for cancer ) The Gold Standard diagnosis is defined as the final diagnosis at 1 year on the basis of the most severe histopathologic result (surgery, biopsy) for that lesion. A retrospective imaging evaluation of mammography versus Combo mode will be performed for the patients diagnosed with a breast cancer lesion. This retrospective imaging evaluation will be conducted centrally within the assessment committee at the lesion, breast and patient level.
次要结局
- performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multicentricity(1 year)
- performance of MG vs Combo (MG+Tomosynthesis) for the diagnosis of multifocality(1 year)