Breast Screening - Risk Adaptive Imaging for Density

Breast Cancer Clinical Trial

— BRAID  

Official title:

Breast Screening - Risk Adaptive Imaging for Density

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04097366
• Other study ID #: A095053
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: October 31, 2026

Study information

• Verified date: November 2022
• Source: University of Cambridge
• Contact: Fiona Gilbert
• Phone: 01223746439
• Email: fjg28[@]medschl.cam.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13200
• Est. completion date: October 31, 2026
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Willing and able to give written informed consent

• Willing and able to comply with the scheduled study visits, tests and other procedures

• Female

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Cheltenham
United Kingdom	Tayside Health Board, Ninewells Hospital	Dundee
United Kingdom	Greater Glasgow Health Board, Gartnavel Royal Hospital	Glasgow
United Kingdom	The Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	University Hospitals of Leicester, Leicester Royal Infirmary	Leicester	Leicestershire
United Kingdom	Barts Health NHS Trust, Royal London Hospital	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	Manchester University NHS Foundation Trust	Manchester
United Kingdom	Nottingham University Hospitals NHS Trust, City Hospital	Nottingham	Nottinghamshire

Sponsors (5)

Lead Sponsor	Collaborator
University of Cambridge	Cancer Research UK, GE Healthcare, Public Health England, Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer detection rate in each arm	All cancers (detected or interval) in each arm over a three year period will be collected.	42 months after mammogram at study entry
Secondary	Incidence of stage II or worse cancers over the period of observation	size, lymph node status, metastatic status	42 months after last participant entered
Secondary	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	6 months after mammogram at study entry
Secondary	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	21 months after mammogram at study entry
Secondary	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	42 months after last participant entered
Secondary	Reading time of each examination	Average time and range for each modality. (Seconds).	1 year
Secondary	Automated breast density measurements compared with reader assessment	Percentage density.	Baseline
Secondary	The risk of developing breast cancer as assessed by the BOADICEA model	Percentage 5 year risk, percentage lifetime risk.	72 months After last participant entered