NCT04097366

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9,000

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

March 30, 2025

Status Verified

May 1, 2024

Enrollment Period

5.3 years

First QC Date

September 9, 2019

Last Update Submit

March 25, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Incidence of stage II or worse cancers over the period of observation

    42 months after last participant entered

  • The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.

    6 months after mammogram at study entry

  • The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.

    21 months after mammogram at study entry

  • The sensitivity and specificity of supplemental imaging with ABB-MRI, CESM and ABUS with standard 2D FFDM.

    42 months after last participant entered

  • Reading time of each examination

    1 year

  • +2 more secondary outcomes

Study Arms (4)

Standard of Care

NO INTERVENTION

Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.

Abbreviated MRI (ABB-MRI)

ACTIVE COMPARATOR

Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.

Diagnostic Test: ABB-MRI

Automated Breast Ultrasound (ABUS)

ACTIVE COMPARATOR

Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.

Diagnostic Test: ABUS

Contrast Enhanced Mammography (CEM)

ACTIVE COMPARATOR

Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.

Diagnostic Test: CEM

Interventions

ABUSDIAGNOSTIC_TEST

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.

Also known as: Whole Breast Ultrasound, Automated Breast Ultrasound
Automated Breast Ultrasound (ABUS)
CEMDIAGNOSTIC_TEST

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.

Also known as: Contrast Enhanced Mammography
Contrast Enhanced Mammography (CEM)
ABB-MRIDIAGNOSTIC_TEST

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.

Also known as: Abbreviated Magnetic Resonance Imaging, Abridged MRI, Abbreviated Protocol MRI, Abbreviated Breast MRII
Abbreviated MRI (ABB-MRI)

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Tayside Health Board, Ninewells Hospital

Dundee, Dundee, DD1 9SY, United Kingdom

Location

Greater Glasgow Health Board, Gartnavel Royal Hospital

Glasgow, Glasgow, G12 0XH, United Kingdom

Location

University Hospitals of Leicester, Leicester Royal Infirmary

Leicester, Leicestershire, LE1 5WW, United Kingdom

Location

Barts Health NHS Trust, Royal London Hospital

London, London, E1 1FR, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, London, NW3 2QG, United Kingdom

Location

Nottingham University Hospitals NHS Trust, City Hospital

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Gloucestershire Hospitals NHS Foundation Trust

Cheltenham, GL53 7AS, United Kingdom

Location

The Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

  • Gilbert FJ, Payne NR, Allajbeu I, Yit L, Vinnicombe S, Lyburn I, Sharma N, Teh W, James J, Seth A, Suaris T, Aggarwal R, Al-Attar M, Savaridas S, Antoniou A, Pharoah P, Duffy S. Comparison of supplemental breast cancer imaging techniques-interim results from the BRAID randomised controlled trial. Lancet. 2025 May 31;405(10493):1935-1944. doi: 10.1016/S0140-6736(25)00582-3. Epub 2025 May 21.

    PMID: 40412427DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fiona Gilbert

    University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology and Head of Department

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 20, 2019

Study Start

May 28, 2019

Primary Completion

September 30, 2024

Study Completion

October 31, 2025

Last Updated

March 30, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(10)