To measure the number of cancers detected by FAST MRI that were missed by screening mammography Cancer
Conditions
Interventions
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 appo
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
Female
Age
49 Years to 53 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 [ = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 17/09/2025: The number of cancers detected on FAST MRI after a negative mammogram, measured using recorded study data at one timepoint Cancers detected by FAST MRI are for those participants whose FAST MRI scans were classified as MRI 3b 4 or 5 and who, on subsequent investigation, had a biopsy-confirmed breast cancer (invasive and non-invasive). A sensitivity analysis will be undertaken to assess the need for additional investigations for the MRI 3 group and whether MRI 3b and/or MRI 3a should be considered as cancers or negative results Previous primary outcome measure: Cancers detected by FAST MRI after a negative mammogram, defined as the FAST MRI scans classified as MRI 3b 4 or 5 with confirmed breast cancer (invasive and non-invasive) on a subsequent biopsy investigation, measured using recorded study data at one timepoint A sensitivity analysis will be undertaken to assess the need for additional investigations for the MRI 3 group and whether MRI 3b and/or MRI 3a should be considered as cancers or negative results | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed using recorded study data and the methods stated below at one timepoint: 1. The characteristics of the cancers detected by FAST MRI (including grade, size, stage, nodal involvement) 2. Acceptability of the intervention through a questionnaire and an additional qualitative interview of a subset of participants 3. Recruitment rate is defined as those that are recruited out of all those with density B that were contacted 4. Retention/compliance rate accounts for the number that withdraw from the study once recruited or do not attend the FAST MRI scan 5. Recall rate, defined as the proportion of women classified with an MRI 3b, 4 or 5 and invited for further investigation out of the total number of recruited women who had a FAST MRI 6. The biopsy rate is calculated as the number of biopsies undertaken out of all women recruited who had a FAST MRI 7. Early call rate, defined as the number of women who have a FAST MRI at y1 (includes all those classified as MRI 3a, and those classified as MRI 3b, 4 and 5 who did not have cancer confirmed at y0 biopsy) out of all women recruited who had a FAST MRI at y0 8. Adverse reactions to FAST MRI 9. The proportion of women in each density category (A, B, C, D) in the UK NHSBSP screened population at this age 10. Interval cancers detected during the study period 11. FAST MRI classifications of y1 scans (for all those with MRI 3a at y0 and those with MRI 3b, 4 and 5 and no cancer detected at y0) 12. FAST MRI reader data, the diagnostic accuracy of readers within the study (individually and by reader group and NHS site), numbers of scans requiring arbitration, standard arbitration outcomes and expert panel arbitration outcomes | — |
Countries
England, United Kingdom
Contacts
Public ContactLyn Jones
Outcome results
None listed