Diagnostic yield study to determine whether an abbreviated form of breast magnetic resonance imaging (FAST MRI) can detect breast cancers missed by screening mammography: for women at population risk of breast cancer with average mammographic density following their initial screening mammogram
To measure the number of cancers detected by FAST MRI that were missed by screening mammography
Current interventions as of 17/09/2025: This study will invite women aged around 50-52 years old to take part. Stage 1: Screening clients will receive study information at their first mammogram appointment (after they have had their mammogram). If the client does not have breast implants, they will be invited to find out if they are eligible to have a FAST MRI - by being asked to consent to the research team looking at their breast screening records and sending their mammogram to the DYAMOND team at Royal Surrey Foundation Trust who will use a computer to measure the breast density. Once the breast density measurement has been done, study teams will look at the results and breast screening records to check if the person is eligible for Stage 2 of the study. Stage 2 The study teams will then send Stage-2 participant information sheets to potentially eligible women - those aged around 50-52, with average / B density breasts, and who have not been recalled by the screening programme. The study team will then contact the participant to discuss participation in Stage 2 - having the FAST MRI scan. 1,000 women will be scanned at NHS sites, chosen for the ethnic diversity of the screened population and the experience the site has in working with FAST MRI. This choice of NHS sites will ensure our sample is representative of the UK population. NHS professionals who have completed FAST MRI reader training will interpret the FAST MRI scans. The total number of cancers detected by FAST MRI and be counted and the types, aggressiveness and size of cancer found will be recorded. The study will also count how many women need further tests but turn out not to have cancer. The study will also look at the results of people who were not eligible for a FAST MRI because they had been recalled by the screening programme and will look at the number and types of cancers found. Participants will be asked to share their experience of having a FAST MRI initially via a survey. The result
Current key inclusion criteria as of 17/09/2025: Stage 1 Consent (Breast Density Measurement): 1. Age [49 years + 8 months] ≤ [53 years – 1 day] at time of mammogram (source: National Breast Screening System (NBSS)) 2. Has had a mammogram via the NHSBSP 3. Willing and able to give informed consent to Stage 1 Stage 2 Consent (FAST MRI DYAMOND scan): 1. First screening mammogram (prevalent round) (source: participant-reported) 2. Participants with breast density category B as determined by AI breast density measurement (source: Scientific Computing Department of Royal Surrey NHS Foundation Trust (RSNFT)) 3. Received standard NHSBSP “no findings” confirmation letter (source: NBSS) 4. No absolute contraindication to breast MRI (source: patient-reported, via completion of Standard Safety Questionnaire) Previous key inclusion criteria: 1. Women with breast density category B 2. Aged [49 years + 8 months] <= [53 years – 1 day] at the time of mammogram 3. Having prevalent round mammogram screening (participant-reported) 4. Received standard NHSBSP “no findings” confirmation letter 5. Willing and able to give informed consent 6. No absolute contraindication to breast MRI
Current key exclusion criteria as of 17/09/2025: Stage 1 Consent (Breast Density Measurement): 1. Has not received a mammogram within the NHSBSP 2. Aged [<49 years + 8 months] or ≥ 53 years at time of mammogram (source: NBSS) 3. Unwilling to have mammograms measured for density 4. Unwilling or unable to give informed consent to Stage 1 5. Breast implants Stage 2 Consent (FAST MRI DYAMOND scan): 1. Breast density category A, C or D or if not determined (source: RSNFT) 2. Known recall after mammogram (source: NBSS) 3. Pregnant or breastfeeding 4. Contraindication to MRI 5. Contraindication to gadolinium-containing contrast agents (GDCA) 6. Unwilling to have FAST MRI 7. Unwilling to allow follow-up of outcomes through data linkage 8. Estimated glomerular filtration rate (eGFR) equal to or below 30 (participant reported) 9. BMI, weight and abdominal girth restrictions may apply to recruiting sites’ MRI scanner(s) that could exclude otherwise eligible participants from having the study intervention. Previous key exclusion criteria: 1. Breast density category A, C or D 2. Known recall after mammogram 3. Has not received a breast mammogram 4. Aged [< 49 years + 8 months] or > = 53 years at time of mammogram 5. Pregnant or breastfeeding 6. Contraindication to MRI 7. Contraindication to gadolinium-containing contrast agents (GDCA) 8. Unwilling to have FAST MRI 9. Unwilling to allow follow-up of outcomes through data linkage 10. Unwilling to have mammograms measured for density 11. eGFR equal to or below 30 12. BMI, weight and abdominal girth restrictions may apply to recruiting sites’ MRI scanner(s) that could exclude otherwise eligible participants from having the study intervention