Status:
ACTIVE_NOT_RECRUITING
Breast Screening - Risk Adaptive Imaging for Density
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cancer Research UK
GE Healthcare
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-70 years
Phase:
NA
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 ...
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 wom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
9000 Patients enrolled
Trial Details
Trial ID
NCT04097366
Start Date
May 28 2019
End Date
October 31 2025
Last Update
March 30 2025
Active Locations (10)
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1
Tayside Health Board, Ninewells Hospital
Dundee, Dundee, United Kingdom, DD1 9SY
2
Greater Glasgow Health Board, Gartnavel Royal Hospital
Glasgow, Glasgow, United Kingdom, G12 0XH
3
University Hospitals of Leicester, Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom, LE1 5WW
4
Barts Health NHS Trust, Royal London Hospital
London, London, United Kingdom, E1 1FR