Breast Screening - Risk Adaptive Imaging for Density (BRAID)

November 22, 2022 updated by: Fiona J Gilbert, University of Cambridge
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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

Enrollment (Anticipated)

13200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Fiona Gilbert
      • Cheltenham, United Kingdom, GL53 7AS
        • Not yet recruiting
        • Gloucestershire Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Sarah Vinnicombe
      • Dundee, United Kingdom, DD1 9SY
        • Recruiting
        • Tayside Health Board, Ninewells Hospital
        • Contact:
        • Principal Investigator:
          • Sarah Savaridas
      • Glasgow, United Kingdom, G12 0XH
        • Recruiting
        • Greater Glasgow Health Board, Gartnavel Royal Hospital
        • Contact:
        • Principal Investigator:
          • Archana Seth
      • Leeds, United Kingdom, LS9 7TF
        • Not yet recruiting
        • The Leeds Teaching Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Nisha Sharma
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free London NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • William Teh
      • London, United Kingdom, E1 1FR
        • Recruiting
        • Barts Health NHS Trust, Royal London Hospital
        • Contact:
        • Principal Investigator:
          • Tamara Suaris
      • Manchester, United Kingdom, M23 9LT
        • Not yet recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Anthony Maxwell
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Recruiting
        • University Hospitals of Leicester, Leicester Royal Infirmary
        • Contact:
        • Principal Investigator:
          • Reena Aggarwal
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham University Hospitals NHS Trust, City Hospital
        • Contact:
        • Principal Investigator:
          • Jonathan James

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other Names:
  • Abbreviated Magnetic Resonance Imaging
  • Abridged MRI
  • Abbreviated Protocol MRI
  • Abbreviated Breast MRII
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.
Other Names:
  • Whole Breast Ultrasound
  • Automated Breast Ultrasound
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.
Other Names:
  • Contrast Enhanced Spectral Mammography
  • Contrast Enhanced Mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
42 months after mammogram at study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
42 months after last participant entered
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
6 months after mammogram at study entry
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
21 months after mammogram at study entry
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
42 months after last participant entered
Reading time of each examination
Time Frame: 1 year
Average time and range for each modality. (Seconds).
1 year
Automated breast density measurements compared with reader assessment
Time Frame: Baseline
Percentage density.
Baseline
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.
72 months After last participant entered

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cambridge

Collaborators

GE Healthcare
Public Health England
Cancer Research UK
Queen Mary University of London

Investigators

  • Principal Investigator: Fiona Gilbert, University of Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2019

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

October 31, 2026

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • A095053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on ABB-MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe