Breast Screening - Risk Adaptive Imaging for Density

Last updated: March 25, 2025
Sponsor: University of Cambridge
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

CEM

ABUS

ABB-MRI

Clinical Study ID

NCT04097366
A095053
  • Ages 50-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing and able to give written informed consent

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

  • 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 toeligibility, there should be a high chance of a cancer being masked in thisparticipant

  • All BIRADS D will be eligible

  • Aged 50-70 and eligible for 3-yearly NHS breast screening

Exclusion

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 (Includingbut not limited to MyPeBS)

  • Participated in part A of the BRAID study

  • Pregnant or breast feeding

Study Design

Total Participants: 9000
Treatment Group(s): 3
Primary Treatment: CEM
Phase:
Study Start date:
May 28, 2019
Estimated Completion Date:
October 31, 2025

Study 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.

Connect with a study center

  • University Hospitals of Leicester, Leicester Royal Infirmary

    Leicester, Leicestershire LE1 5WW
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals NHS Trust, City Hospital

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Gloucestershire Hospitals NHS Foundation Trust

    Cheltenham, GL53 7AS
    United Kingdom

    Site Not Available

  • Tayside Health Board, Ninewells Hospital

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • Greater Glasgow Health Board, Gartnavel Royal Hospital

    Glasgow, G12 0XH
    United Kingdom

    Site Not Available

  • The Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust, Royal London Hospital

    London, E1 1FR
    United Kingdom

    Site Not Available

  • Royal Free London NHS Foundation Trust

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Manchester University NHS Foundation Trust

    Manchester, M23 9LT
    United Kingdom

    Site Not Available

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