Breast Screening - Risk Adaptive Imaging for Density

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: ABB-MRI; Diagnostic Test: ABUS; Diagnostic Test: CESM

• Registration Number: NCT04097366
• Lead Sponsor: University of Cambridge

Brief 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.

Detailed 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 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 Timeline

• Study Start: 2019-05-28
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Status Verified: 2024-05
• Primary Completion: 2024-09-30
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 9000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abbreviated MRI (ABB-MRI)	ABB-MRI	Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.
Automated Breast Ultrasound (ABUS)	ABUS	Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.
Contrast Enhanced Mammography (CESM)	CESM	Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.

Primary Outcome Measures

Name	Time	Method
Cancer detection rate in each arm	42 months after mammogram at study entry	All cancers (detected or interval) in each arm over a three year period will be collected.

Secondary Outcome Measures

Name	Time	Method
Reading time of each examination	1 year	Average time and range for each modality. (Seconds).
The risk of developing breast cancer as assessed by the BOADICEA model	72 months After last participant entered	Percentage 5 year risk, percentage lifetime risk.
The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.	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
Automated breast density measurements compared with reader assessment	Baseline	Percentage density.
Incidence of stage II or worse cancers over the period of observation	42 months after last participant entered	size, lymph node status, metastatic status

Trial Locations

Locations (10)

University Hospitals of Leicester, Leicester Royal Infirmary; 🇬🇧 Leicester, Leicestershire, 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

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

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