Innovation in Mammography: Tomosynthesis Pathways
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,000
- 试验地点
- 4
- 主要终点
- the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +)
研究概览
简要总结
The study aims at evaluating the introduction of tomosynthesis in mammography screening, analyzing the benefits, disadvantages and feasibility in current clinical practice.
It involves women aged 45-46 that will be divided, by drawing lots, into two groups: one group will do the 2D digital mammography (control group), while the other group (intervention group) will do tomosynthesis. In the intervention group the 2D two-dimensional mammography will be reconstructed starting from tomosynthesis without exposing women to other radiation.
详细描述
The IMPETO trial is a population-based, multicentre, randomised trial aimed at evaluating the clinical accuracy of Digital Breast Tomosynthesis (DBT) in adjunct to synthetic mammograms (sDM) compared to standard two-dimensional digital mammography alone (2D) in a screening programme.
45-46 year-old women resident in the screening centre catchment area of Florence and South-Est Local Health Unit are invited to attend for mammography screening and asked for informed consent to be included in the study. Women are then randomly allocated either to an usual care group (2D mammography) or to the intervention group. In the intervention group, DBT combined with sDM is proposed in order to reduce radiation exposure. The next year women of both groups will be invited to attend the usual screening examination (2D mammography). The enrolment will last 12-18 months; the whole study 36 months. The estimated sample size is 6000 women, 3000 per arm. Data will be pooled with the trial "Screening for Breast Cancer With Digital Breast Tomosynthesis", ClinicalTrials.gov Identifier: NCT02698202.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •45-46 years old women resident in the screening area
排除标准
- •previous breast cancer
- •written refusal to participate in the screening programme
- •pregnancy, breastfeeding
- •presence of prostheses;
- •ongoing chemotherapy;
- •impossibility to submit the informed consent for linguistic problems or for inability of women to provide informed consent;
- •verified presence of BRCA1 - BRCA2 (Breast Related Cancer Antigens 1 - Breast Related Cancer Antigens 2) genetic mutation or involvement in surveillance path for heredo-familial tumor;
- •previous known tomosynthesis.
结局指标
主要结局
the cumulative incidence of advanced screen-detected cancers (T2 +) and the cumulative incidence of advanced interval cancers (T2 +)
时间窗: three years
number of T2+ screen-detected cancers divided by all screened women at subsequent round of screening and number of T2+ interval cancers divided by all screened women at subsequent round of screening.
次要结局
- benign biopsies rate(two years)
- detection rate(two years)
- cost analysis(two years)
- recall rate(two years)