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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

Tracking Information
First Submitted Date  ICMJE September 9, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • 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
  • 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
  • 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
  • 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
  • Reading time of each examination [ Time Frame: 1 year ]
    Average time and range for each modality. (Seconds).
  • Automated breast density measurements compared with reader assessment [ Time Frame: Baseline ]
    Percentage density.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breast Screening - Risk Adaptive Imaging for Density
Official Title  ICMJE Breast Screening - Risk Adaptive Imaging for Density
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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Diagnostic Test: ABB-MRI
  • Active Comparator: Automated Breast Ultrasound (ABUS)
    Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.
    Intervention: Diagnostic Test: ABUS
  • Active Comparator: Contrast Enhanced Mammography (CESM)
    Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.
    Intervention: Diagnostic Test: CESM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2019)
13200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2026
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fiona Gilbert 01223746439 fjg28@medschl.cam.ac.uk
Contact: Miranda Townsend 01223336892 mjt205@medscl.cam.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097366
Other Study ID Numbers  ICMJE A095053
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Fiona J Gilbert, University of Cambridge
Study Sponsor  ICMJE University of Cambridge
Collaborators  ICMJE
  • Cancer Research UK
  • GE Healthcare
  • Queen Mary University of London
  • Public Health England
Investigators  ICMJE
Principal Investigator: Fiona Gilbert University of Cambridge
PRS Account University of Cambridge
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP