Title: Real World Evidence Driving Changes in Crohn’s Disease Management Using Quantitative Imaging Analysis
Funder: Department of Health and Social Care

Abstract: Background Crohn s Disease is a chronic condition affecting 115,000 people in the UK and is managed with powerful drugs to control intestinal inflammation. A well-managed patient can avoid surgery and live long and otherwise normal life. Although the drugs can be very effective initially, they have a 60% one year failure rate and are very expensive. We currently lack objective tests to monitor response to therapy, meaning that many patients get worse while on treatment. This project Recently, the SME Motilent has CE marked a software tool called GIQuant that allows objective analysis of Crohn's MRI data. Using GIQuant, a radiologist can quickly produce a numerical score for disease activity that the gastroenterologist can use to help determine treatment. An increase in the GIQuant score suggests response to treatment in small bowel Crohn's. GIQuants potential to improve the efficacy of treatment decision in Crohn's is the main, high level driver for clinical adoption. However, more granular detail is needed on financial impact to enable initial, short-term clinical adoption. For this project, a highly experienced, multi-disciplinary team has come together to capture the efficiency impacts GIQuant may have on the clinic. Specifically GIQuant will likely enable radiologists to drop the use of contrast agent (&pound;50-100 per scan) in many cases and allow a shorter overall scan time. With nearly 40,000 small bowel MRI's performed each year in the NHS, this small but well evidenced cost saving will represent a strong payer-driven motivation for initial adoption from which the potential for quantitative imaging in Crohn's can expand leading to improvements in care. Deliverables Real world data supporting a shorter, cheaper and objective GIQuant enabled MRI service for Crohn's Disease in the NHS.

Lay abstract: The problem Crohn s Disease is a chronic, inflammatory condition of the intestines affecting 180,000 people in the UK. Patients are typically diagnosed when they are young, and will spend the remainder of their lives in and out of hospital and taking powerful anti-inflammatory medication. The drugs used in Crohn s are expensive, ranging from &pound;3,000 to &pound;15,000 per patient/year (the NHS is expected to spend more than &pound;400m in 2020). The high failure rates of these medications result in wastage for healthcare systems. One of the best ways to tackle these costs is with improved monitoring tests so we can see when a drug is working. Crohn s patients regularly undergo a range of tests and Magnetic Resonance Imaging (MRI) is routinely used in the UK. MRI is non-invasive, doesn't use radiation (safe) and can identify areas of inflammation. Its main limitation is it's expensive, we don't have enough scanners and the results it provides are subjective. The SME Motilent was founded to improve our understanding of the gastrointestinal tract in health and disease. Motilent s first product, GIQuant&reg;, was in part funded by the NIHR to provide quantitative measure from routine clinical MRI data to tell doctors how well their drugs are working. GIQuant&reg; has been CE Marked and is ready for widespread use in adults and children. What are we going to do in this project? The clinical research data shows that GIQuant&reg; is objective with good performance against the endoscopic gold standard, fast to use and does not require an injected contrast agent. Importantly, GIQuant&reg; may save up to 15mins of scan time and &pound;50 &ndash; &pound;150 in materials use (e.g. needles and contrast agents). The goal of this project is to capture this performance data in the real world, in busy clinics around the UK. These data will provide compelling evidence to the NHS that GIQuant&reg; can be used cost-effectively to improve the way we look after patients with Crohn's Disease specifically through reducing dependence on expensive elements of the MRI test like IV contrast. This research will help inform the economic case for adoption and enable evidence driven uptake and patient benefit. Where will we be at the end of this project? At the end of this project we hope to have the evidence required to shorten MRI scan times without impacting a radiologists performance. We'll have a strong business case to enable uptake in the NHS. For the first time, gastroenterologists will have an objective MRI score to track Crohn's Disease to help patients get better faster.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: ORAL AND GASTROINTESTINAL