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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
9,000
Automated whole breast ultrasound (ABUS) is undertaken with a large transducer panel placed on the breast in three positions. Resultant images are combined to make a 3D image of the breast.
A high kV and a low kV image is taken in two standard views of each breast following the intravenous injection of an iodinated contrast agent.
ABB-MRI is a shorter version of breast MRI. Standard T1W pre and post contrast images are acquired. A MIP and post-contrast T1 weighted image are read.
Tayside Health Board, Ninewells Hospital
Dundee, Dundee, United Kingdom
Greater Glasgow Health Board, Gartnavel Royal Hospital
Glasgow, Glasgow, United Kingdom
University Hospitals of Leicester, Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom
Cancer detection rate in each arm
All cancers (detected or interval) in each arm over a three year period will be collected.
Time frame: 42 months after mammogram at study entry
Incidence of stage II or worse cancers over the period of observation
size, lymph node status, metastatic status
Time frame: 42 months after last participant entered
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at prevalent round
Time frame: 6 months after mammogram at study entry
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates
Time frame: 21 months after mammogram at study entry
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.
Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at incident round; Interval cancer rate; Stage of interval cancers; Size of interval cancers
Time frame: 42 months after last participant entered
Reading time of each examination
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Barts Health NHS Trust, Royal London Hospital
London, London, United Kingdom
Royal Free London NHS Foundation Trust
London, London, United Kingdom
Nottingham University Hospitals NHS Trust, City Hospital
Nottingham, Nottinghamshire, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Average time and range for each modality. (Seconds).
Time frame: 1 year
Automated breast density measurements compared with reader assessment
Percentage density.
Time frame: Baseline
The risk of developing breast cancer as assessed by the BOADICEA model
Percentage 5 year risk, percentage lifetime risk.
Time frame: 72 months After last participant entered