Award Title: Real-world testing of software for measuring bone disease on whole-body MRI in patients with prostate cancer and myeloma
Funder: Department of Health and Social Care

Abstract: Research question  Can using WBMRI and our novel software result in faster, more accurate and/or more confident disease assessment  compared with conventional pathways in patients with bone disease from advanced prostate cancer and myeloma?  Background  WBMRI is useful for assessing bone disease extent and response to treatment by measuring the total disease volume (tDV) and apparent diffusion coefficient (ADC), but requires software to quantify these for clinical application. We have developed a CE-labelled software which can automatically measure the tDV and ADC from WBMRI to assess bone disease.   Aims and objectives  The aim is to test the real-world performance of our CE-labelled computer software with WBMRI to measure bone disease, by assessing its clinical performance, identify barriers to adoption, and roadmap its wider adoption.  The objectives are to: (1) map the interactions of our software with stakeholders; (2) validate use of training for doctors to promote technology uptake; (3) test the performance of WBMRI and software for assessing bone disease response to treatment in prostate cancer and for diagnosing myeloma; (4) determine costs and cost-effectiveness; and (5) evaluate commercial models for NHS deployment.  Methods  We will (1) evaluate relevant human factors and software usability to refine product; (2) develop and validate training to utilise WBMRI and software; (3) undertake two clinical trials in advanced prostate cancer and myeloma to determine clinical effectiveness; (4) perform health-economic analysis; and (5) explore commercial models for dissemination.    Timelines for delivery  WP1 [month 3-39]; WP2 [month 1 to 24]; WP3 [month 7 to 48]; WP4 [month 1-6 and 36-48]; WP5 [1-48].  Anticipated impact and dissemination  Improved disease management and outcomes for patients; new diagnostic skills and/or faster reporting for radiologists; increased clinician confidence in decision making; standardised cost-effective WBMRI service for the NHS; investment in the UK contributing to economic growth.

Lay Abstract: The spread of cancer to bones is common. In advanced prostate cancer, bone disease can occur in 90% of patients. In myeloma, a cancer of the bone marrow, 70% of patients have bone damage at diagnosis.  Currently, computed tomography (CT) and bone scan imaging (BS) are used to detect cancer spread to bones. However, neither reliably identifies the extent of the disease (myeloma), nor whether treatment is working (prostate).  Whole body MRI (WBMRI) is more sensitive for bone cancer and better for assessing whether cancer treatments are working. Despite this, CT and BS are still widely used across the NHS, with patients missing out on WBMRI. As a result, some patients may not get the right treatment and are kept on ineffective treatments for longer, leading to poorer disease outcomes.    As WBMRI is relatively new, doctors  may need training to be confident about using it. However, standard WBMRI reports by doctors can lack precision. For example, one doctor s idea of “a small amount ” of disease may be different from another. Hence, accurate measurements from WBMRI are necessary to allow the effects of cancer treatments to be objectively monitored.    Through an NIHR Invention for Innovation funded project, we have developed a CE-labelled (meeting a safety conformity standard) software which can automatically identify and measure bone disease on WBMRI. The software quickly extracts the total amount of bone disease and its cellular property.  The software has been shown to be reliable and accurate for bone disease assessment in prostate cancer.  We will test the real-world performance of our software in patients with bone disease from prostate cancer and myeloma. We will study how our software interacts with the users and identify any barriers for use. We will also conduct clinical trials to show its performance.   We will undertake our research in five work packages: (1) we will study user interactions with our software and perform a usability analysis to help refine the software; (2) we will create and apply a training module for doctors and scan technicians to encourage WBMRI and software adoption; (3) we will undertake two clinical trials to show the performance of our software and WBMRI compared with standard pathways; (4) we will determine whether using WBMRI and our software is cost-effective; and (5) we will study the commercial approaches to get our software adopted by the NHS.   Identified by our patient and public involvement representatives as a priority, this study will generate meaningful impact by showing that using WBMRI and our software can provide faster, more accurate and/or higher diagnostic confidence for assessing bone disease. This can lead to greater confidence that the right treatment is given at the right time, thereby improving longer term patient outcomes.

Research Activity Codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health Categories: CANCER AND NEOPLASMS