Title: Refinement and piloting of a training programme within the NHS Breast Screening Programme (NHSBSP) workforce of image readers to enable standardised interpretation of a shortened magnetic resonance imaging scan (MRI) of the breast called FAST MRI to support the delivery of a future multicentre trial of FAST MRI versus mammogram for breast cancer screening
Funder: Department of Health and Social Care

Abstract: Research question: Is it feasible to train NHS breast screening programme (NHSBSP) mammogram-readers to interpret FAST MRI, in preparation for a substantive trial comparing FAST MRI with mammograms? Background: Early diagnosis of breast cancer (BC) saves lives and is the aim of NHSBSP, but screening with mammograms fails to prevent some stage 2-4 BCs (underdiagnosis), which often present symptomatically between screening rounds (interval cancers). Therefore, despite effective treatments, BC remains the second most common cause of oncological mortality for women in the UK. Both underdiagnosis and overdiagnosis are explained by the diversity of BC biology with some indolent cancers well shown on mammograms but unlikely to cause harm, and other aggressive, biologically-relevant cancers not well shown on mammograms but likely to progress to stage 2-4 disease if undetected. Breast MRI (DCE-MRI) is the best test for BC and is a radiogenomic biomarker for aggressive disease, but high cost prevents its use in screening for all but those at highest risk. A type of abbreviated breast MRI called FAST MRI retains the component of DCE-MRI that identifies biologically-relevant BCs, and its short acquisition and reading times promise potential cost-effectiveness. Integration of any new test into NHSBSP requires workforce training. If training proves expensive and prolonged, the test becomes unfeasible on these grounds alone. Therefore, we need to know whether NHSBSP mammogram-readers can learn to interpret FAST MRI with brief additional training, matching reported capabilities of expert DCE-MRI readers for accuracy and interpretation speed. Aims and objectives: To refine and pilot a training programme for FAST MRI within the NHSBSP workforce, to support delivery of a future multicentre study of FAST MRI versus mammogram for BC screening Methods: The applicants have developed and piloted a standardised teaching-tool for FAST MRI, and also a data-collection-tool, measuring accuracy and speed of interpretation, with a dataset of 125 anonymised FAST MRI scans (250 breasts) of known outcome. Through partnership with SciCom, both tools will be developed into electronic versions. Following validation, these electronic tools will be piloted across 6 NHSBSP sites in England. Recruited readers will be grouped according to their usual practice within NHSBSP: Group 1 reading both DCE-MRI and mammograms, and Group 2 reading mammograms alone. Once trained, readers will assess the 250 breasts using the electronic data-collection-tool, allowing analysis of accuracy and interpretation-speed of the two groups of readers. A Budget Impact Analysis (BIA) of FAST MRI on the NHS will be conducted in parallel. Timelines for delivery: Months 1-5: Development of electronic tools, Months 4-13: reader-training, data-collection and BIA, Months 15-18: Dissemination, report-writing and preparation for HTA grant application for the substantive prospective study. Anticipated impact and dissemination: Evidence provided by this study and the substantive study will potentially enable women at moderate risk of BC to be screened with FAST MRI as part of stratified/personalised screening. The patient-benefit derived will be the lives saved from biologically-relevant BC being found at an early stage by FAST MRI that would otherwise have been missed by mammogram.

Lay abstract: Aim: To see if NHS staff can successfully learn to use a new method of breast cancer screening to find breast cancers early Background: Finding breast cancers early saves lives. Mammograms are the X-ray test that the NHS uses to look for early signs of breast cancer. Mammograms are better at finding some types of breast cancer than others. Unfortunately, fast-growing, dangerous cancers are less likely to show up on a mammogram than slow-growing cancers. Also, half the women having breast cancer screening in the UK have enough dense (solid or tightly packed) breast tissue to hide a small cancer on their mammogram. In order to save more lives by finding fast-growing breast cancers early, we need an affordable screening test that is better than mammograms at finding cancers. We also need to know if the NHS staff who read the screening mammograms can quickly learn to interpret the new test accurately. There is a high-tech test (known as MRI) that is better than mammograms at finding breast cancers. However, each MRI scan takes about half an hour, and needs senior medical staff to interpret it. This makes it expensive and it cannot be used for everyone. FAST MRI is a quicker type of MRI and we think it could be better than mammograms at finding breast cancers early. Design and Methods used: We will teach staff from 6 NHS centres to interpret FAST MRI. The staff will already be able to read mammograms. Once trained, they will read a set of 250 FAST MRI scans, looking for signs of breast cancer. We want to see how accurate their readings are and find out if our teaching methods are good enough. Patient and Public Involvement (PPI): Patients and the public have given us a lot of support and many are involved in this study. This includes support from the following organisations. &bull; Breast Cancer Unit Support Trust (BUST) &bull; National Cancer Research Institute (NCRI) Breast Clinical Studies Group (CSG) &bull; NCRI Screening, Prevention and Early Diagnosis (SPED) CSG &bull; Independent Cancer Patients Voice (ICPV) What will we do with the results? We plan to publish the results in academic journals and present them at national meetings. The public and patients involved in this study will help us to tell the results to everyone who could be interested in them, including for example breast cancer charities. What next? Once this study is complete, we want to test whether FAST MRI scans could replace mammograms for some women, as their breast cancer screening test, in the future. We will need to apply for extra money (research grant) to do this.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.4 POPULATION SCREENING
Health categories: CANCER AND NEOPLASMS