Clinical trial · Interventional
Breast Screening - Risk Adaptive Imaging for Density
NCT04097366CI-TRIAL-00087875BRAIDunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABB-MRI | Diagnostic Test | — | UNRESOLVED |
| ABUS | Diagnostic Test | — | UNRESOLVED |
| CEM | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.
- type
- ACTIVE_COMPARATOR
- label
- Abbreviated MRI (ABB-MRI)
- description
- Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.
- interventionNames
- Diagnostic Test: ABB-MRI
- type
- ACTIVE_COMPARATOR
- label
- Automated Breast Ultrasound (ABUS)
- description
- Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGilbert 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 40412427