Breast Screening - Risk Adaptive Imaging for Density (BRAID)
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|ClinicalTrials.gov Identifier: NCT04097366|
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Diagnostic Test: ABUS Diagnostic Test: CESM Diagnostic Test: ABB-MRI||Not Applicable|
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 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 (CESM). 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 (Clinical Trial)|
|Estimated Enrollment :||13200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Breast Screening - Risk Adaptive Imaging for Density|
|Actual Study Start Date :||May 28, 2019|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||October 31, 2026|
No Intervention: Standard of Care
Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.
Active Comparator: Abbreviated MRI (ABB-MRI)
Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.
Diagnostic Test: ABB-MRI
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.
Active Comparator: Automated Breast Ultrasound (ABUS)
Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.
Diagnostic Test: ABUS
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.
Active Comparator: Contrast Enhanced Mammography (CESM)
Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.
Diagnostic Test: CESM
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.
- Cancer detection rate in each arm [ Time Frame: 42 months after mammogram at study entry ]All cancers (detected or interval) in each arm over a three year period will be collected.
- Incidence of stage II or worse cancers over the period of observation [ Time Frame: 42 months after last participant entered ]size, lymph node status, metastatic status
- The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM. [ Time Frame: 6 months after mammogram at study entry ]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
- The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM. [ Time Frame: 21 months after mammogram at study entry ]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
- The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM. [ Time Frame: 42 months after last participant entered ]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
- Reading time of each examination [ Time Frame: 1 year ]Average time and range for each modality. (Seconds).
- Automated breast density measurements compared with reader assessment [ Time Frame: Baseline ]Percentage density.
- The risk of developing breast cancer as assessed by the BOADICEA model [ Time Frame: 72 months After last participant entered ]Percentage 5 year risk, percentage lifetime risk.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097366
|Contact: Fiona Gilbertfirstname.lastname@example.org|
|Contact: Miranda Townsendemail@example.com|
|Cambridge University Hospitals NHS Foundation Trust||Recruiting|
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Fiona Gilbert 01223746439 firstname.lastname@example.org|
|Principal Investigator: Fiona Gilbert|
|Gloucestershire Hospitals NHS Foundation Trust||Not yet recruiting|
|Cheltenham, United Kingdom, GL53 7AS|
|Contact: Sarah Vinnicombe email@example.com|
|Principal Investigator: Sarah Vinnicombe|
|The Leeds Teaching Hospitals NHS Trust||Not yet recruiting|
|Leeds, United Kingdom, LS9 7TF|
|Contact: Nisha Sharma firstname.lastname@example.org|
|Principal Investigator: Nisha Sharma|
|Manchester University NHS Foundation Trust||Not yet recruiting|
|Manchester, United Kingdom, M23 9LT|
|Contact: Anthony Maxwell email@example.com|
|Principal Investigator: Anthony Maxwell|
|Principal Investigator:||Fiona Gilbert||University of Cambridge|