Breast Screening - Risk Adaptive Imaging for Density
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 9,000
- 试验地点
- 10
- 主要终点
- Cancer detection rate in each arm
研究概览
简要总结
BRAID is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the UK national breast screening programme who have dense breast tissue.
详细描述
Breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. Women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. High breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. Women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage.
The UK national breast screening programme (NHS BSP) offers all women aged 50-70 screening with 3-yearly mammograms. It aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. However only 53% of the cancers being detected are small (<15mm). This is partly due to masking of cancers by dense breast tissue.
This trial addresses how best to screen women with dense breasts for breast cancer. BRAID will randomise women whose recent screening normal mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated MRI (ABB-MRI), automated whole breast ultrasound (ABUS) or contrast enhanced spectral mammography (CEM). These imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. Our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging.
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
- 50 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give written informed consent
- •Willing and able to comply with the scheduled study visits, tests and other procedures
- •Screening mammogram that is either normal or being recalled for assessment
- •Increased breast density identified on current screening mammogram examination (BIRADS C or D)
- •If BIRADS C the reporting radiologist should use clinical judgement as to eligibility, there should be a high chance of a cancer being masked in this participant
- •All BIRADS D will be eligible
- •Aged 50-70 and eligible for 3-yearly NHS breast screening
排除标准
- •Known BRCA carrier or ≥50% risk of being a carrier
- •Unable to give informed consent
- •Breast implant(s)
- •Unable to be followed-up for the study duration
- •Current participation in another interventional breast screening trial (Including but not limited to MyPeBS)
- •Participated in part A of the BRAID study
- •Pregnant or breast feeding
研究组 & 干预措施
Standard of Care
Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.
Abbreviated MRI (ABB-MRI)
Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.
干预措施: ABB-MRI (Diagnostic Test)
Automated Breast Ultrasound (ABUS)
Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.
干预措施: ABUS (Diagnostic Test)
Contrast Enhanced Mammography (CEM)
Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.
干预措施: CEM (Diagnostic Test)
结局指标
主要结局
Cancer detection rate in each arm
时间窗: 42 months after mammogram at study entry
All cancers (detected or interval) in each arm over a three year period will be collected.
次要结局
- Reading time of each examination(1 year)
- The risk of developing breast cancer as assessed by the BOADICEA model(72 months After last participant entered)
- The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.(42 months after last participant entered)
- Automated breast density measurements compared with reader assessment(Baseline)
- Incidence of stage II or worse cancers over the period of observation(42 months after last participant entered)
- The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.(6 months after mammogram at study entry)
- The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.(21 months after mammogram at study entry)
研究者
Fiona J Gilbert
Professor of Radiology and Head of Department
University of Cambridge
