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Breast Screening - Risk Adaptive Imaging for Density (BRAID)

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ClinicalTrials.gov Identifier: NCT04097366
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Cancer Research UK
GE Healthcare
Queen Mary University of London
Public Health England
Information provided by (Responsible Party):
Professor Fiona J Gilbert, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: ABUS Diagnostic Test: CESM Diagnostic Test: ABB-MRI Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Breast Screening - Risk Adaptive Imaging for Density
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 31, 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Reading time of each examination [ Time Frame: 1 year ]
    Average time and range for each modality. (Seconds).

  6. Automated breast density measurements compared with reader assessment [ Time Frame: Baseline ]
    Percentage density.

  7. 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.



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097366


Contacts
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Contact: Fiona Gilbert 01223746439 fjg28@medschl.cam.ac.uk
Contact: Miranda Townsend 01223336892 mjt205@medscl.cam.ac.uk

Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Fiona Gilbert    01223746439    fjg28@medschl.cam.ac.uk   
Principal Investigator: Fiona Gilbert         
Gloucestershire Hospitals NHS Foundation Trust Not yet recruiting
Cheltenham, United Kingdom, GL53 7AS
Contact: Sarah Vinnicombe       sarah.vinnicombe@nhs.net   
Principal Investigator: Sarah Vinnicombe         
The Leeds Teaching Hospitals NHS Trust Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Nisha Sharma       nisha.sharma2@nhs.net   
Principal Investigator: Nisha Sharma         
Manchester University NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M23 9LT
Contact: Anthony Maxwell       anthony.maxwell@manchester.ac.uk   
Principal Investigator: Anthony Maxwell         
Sponsors and Collaborators
University of Cambridge
Cancer Research UK
GE Healthcare
Queen Mary University of London
Public Health England
Investigators
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Principal Investigator: Fiona Gilbert University of Cambridge

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Responsible Party: Professor Fiona J Gilbert, Professor of Radiology and Head of Department, University of Cambridge
ClinicalTrials.gov Identifier: NCT04097366     History of Changes
Other Study ID Numbers: A095053
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No