Testing whether a fast MRI scan can detect breast cancers which were not detected on mammograms, in women with average breast density
| ISRCTN | ISRCTN74193022 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74193022 |
| IRAS number | 330059 |
| Secondary identifying numbers | CPMS 59828, NIHR150502 |
- Submission date
- 30/09/2024
- Registration date
- 04/10/2024
- Last edited
- 25/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Finding breast cancers early saves lives. The NHS Breast Screening Programme (NHSBSP) uses either mammograms (quick X-rays) or magnetic resonance imaging (MRI) scans to find breast cancers as early as possible. Mammograms are used most widely as they are quick but are less good at finding the most aggressive cancers early. MRIs are better at detecting small aggressive cancers but take longer and are expensive, so are only offered to people at the highest risk of getting breast cancer. A newer type of scan is the “FAST” MRI scan. This is quicker than standard MRI and may be better at detecting small cancers than mammograms. Until now, researchers worldwide have focussed on women with high breast density to test if FAST MRI can find breast cancers early. This means that, until now, women with average breast density have been unable to take part in research about FAST MRI. The DYAMOND study will test if a FAST MRI can detect cancers not seen on a first screening mammogram, for women with average-density breasts. If this study shows that cancers not found by a mammogram can be found by FAST MRI for women with average-density breasts, this group of women will be included in a larger study to see if FAST MRI is a good alternative to mammograms for breast screening.
Who can participate?
Women will be invited for a FAST MRI if they are aged 50-52 years old, their mammogram does not show cancer and their breast density is “average” (a computer measures this from mammogram images).
What does the study involve?
All DYAMOND participants will have a FAST MRI as well as their standard screening mammogram. Some participants will have a second FAST MRI 1 year later.
Trained health professionals will check the FAST MRI images. If any cancers are found, the women will be looked after by their local hospital, which will collect information about their care for the DYAMOND study team. Women will be asked their thoughts about having the FAST MRI scan to understand their experiences.
What are the possible benefits and risks of participating?
Benefits: The FAST MRI scan may find breast cancer earlier than it would have been found without the DYAMOND study. Treatments are more effective when a cancer is detected early and so this could prevent the participant from dying from their breast cancer.
Risks: To have a FAST MRI, participants will need to have an injection into a vein in their arm at the time of the scan. Hospitals worldwide use this type of injection every day for standard MRI scans of many different parts of the body. The MRI radiographers will follow all standard safety procedures for the injection and the scan during DYAMOND.
Where is the study run from?
North Bristol NHS Trust is running the study. Women can join the study from NHS Breast Screening Services, including Avon, Gloucestershire, Cornwall, Wiltshire, South West London and South East London.
When is the study starting and how long is it expected to run for?
May 2023 to October 2024
Who is funding the study?
The Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR) jointly fund the DYAMOND Study through the Efficacy and Mechanism Evaluation (EME) funding stream of the NIHR
Who is the main contact?
1. Dr Lyn Jones: FASTMRI@nbt.nhs.uk
2. Dr Rebecca Geach: FASTMRI@nbt.nhs.uk
Plain English summary under review with external organisation
Contact information
Public, Scientific, Principal Investigator
Research and Development, Level 3 Learning & Research Building, Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0001-7439-7037 |
|---|---|
| Phone | +44 (0)1174149330 |
| Lyn.Jones@nbt.nhs.uk |
Study information
| Study design | Non-randomised controlled feasibility/pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Internet/virtual, Medical and other records, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | FAST MRI: DYAMOND |
| Study objectives | This research aims to refine the study design and define the study population, for a future randomised controlled trial (RCT) of FAST MRI as a screening modality for women having their first mammographic screen with the NHS breast screening programme (BSP) (future application to NIHR). Specifically, the proposed work will determine if women with average mammographic density (BI-RADS category B) could benefit from screening with FAST MRI and fill the knowledge gap. The hypothesis this proposal will test is that FAST MRI can detect breast cancers missed by mammography for the 40% of the population of women having their first mammogram with NHSBSP (age 50-52) who have category B mammographic density. The findings of this study will be important, no matter whether the hypothesis is proved or disproved because they will justify either the inclusion or the exclusion of 40% of the screened population (not previously investigated) in a future study proposal to NIHR (HTA) for a randomised controlled trial (RCT) of FAST MRI. |
| Ethics approval(s) |
Approved 09/01/2024, Yorkshire & the Humber – Sheffield (NHS Blood & Transplant Centre, Holland Drive, Newcastle-upon-Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8388; sheffield.rec@hra.nhs.uk), ref: 23/YH/0268 |
| Health condition(s) or problem(s) studied | To measure the number of cancers detected by FAST MRI that were missed by screening mammography |
| Intervention | This study will invite women aged around 50-52 years old to take part. They will receive study information at their first mammogram appointment (after they have had their mammogram). 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. This is Stage 1 of DYAMOND participation. 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. The study teams will then send Stage-2 participant information leaflets 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. The results will help to decide which women should be included in a future FAST MRI trial to measure if FAST MRI would be a good scan for the NHS to use for breast screening. |
| Intervention type | Procedure/Surgery |
| 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 outcome measures | 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 |
| Overall study start date | 01/05/2023 |
| Completion date | 31/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 49 Years |
| Upper age limit | 53 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 1000; UK Sample Size: 1000 |
| 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 |
| 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 |
| Date of first enrolment | 25/10/2024 |
| Date of final enrolment | 30/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Cheltenham
GL53 7AN
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
London
SE5 9RS
United Kingdom
Truro
TR1 3LJ
United Kingdom
Swindon
SN3 6BB
United Kingdom
Sponsor information
Hospital/treatment centre
Southmead Hospital, Southmead Road, Westbury-On-Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)1174149330 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
| Website | https://www.nbt.nhs.uk/ |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The data is owned by the Sponsor, North Bristol NHS Trust. Scientific audience The protocol for the study will be published in a peer-reviewed journal and the results of the study presented at National and International meetings on behalf of North Bristol NHS Trus. These publications and presentations will acknowledge the sponsor and funder of the study. On completion of the trial, the data will be analysed, and tabulated, and final study reports will be sent to the relevant authorities (funder, HRA, NHSBSP Research Innovation and Dissemination Advisory Committee). The primary outcome paper will be submitted to an open-access peer-reviewed journal. Public audience A lay summary will be disseminated to: 1. All involved bodies (e.g., public and patient charities and support groups involved in the DYAMOND study, including BUST, Independent Cancer Patient's Voice, Breast Density Matters UK). 2. Formal PPIE group. 3. FAST MRI mailing list. 4. Uploaded to the FAST MRI website. 5. All FAST MRI readers within the study. 6. All participants Social media will also promote these findings through the NBT Research and Development teams and the FAST MRI X (Twitter) account. Sites that have taken part in the study will also be allowed to disseminate the findings. |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon reasonable request at the end of the study from Dr Lyn Jones, FASTMRI@nbt.nhs.uk. Consent for the storage and use of anonymised data for health-related research purposes is obtained from all participants during DYAMOND study recruitment. |
Editorial Notes
25/10/2024: The ethics approval was added.
30/09/2024: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
