Title: Evaluation of Crohn’s disease activity with MRI: adding value through quantitative assessment of intestinal motility
Funder: Department of Health and Social Care

Abstract: Milestones: 1. ISO:13485 certified quality management system (12 months). 2. CE Mark GIQuantTM (18 months) 3. Licensing of GIQuantTM to UCLH (24 months) There are four work packages (WPs) across technical, regulatory, health economic and clinical implementation to address the study objectives. A clinical work-package is not included as a supportive literature already exists and multi-centre prospective studies are currently underway (CI Taylor, co-applicant) providing further safety and efficacy information to meet regulatory approval. In particular, an NIHR trial funded by the EME stream (14/201/16) is investigating the ability of GIQuantTM to predict 1-year treatment response to anti-TNF medication. This 10-centre UK study will recruit 156 patients starting anti TNF therapy and undertake motility MRI at time 0, week 20-28 and week 52. WP1 Technical Objective: Develop a CE marked service built around the GIQuantTM technology. WP1.1 Establish robust development environment (month 0-3) WP1.2 Complete web-based portal for user testing and finalise GIQuantTM product design along with risk register (month 3-14) WP1.3 Complete optimised clinical portal, deployed securely (month 14-24) Rationale: The software solution must be flexible and meet user requirements across different hospitals without relying on existing hardware. Deliverable: Installation requirements and product for clinical use. WP2 Regulatory Objective: Obtain market clearance for GIQuantTM. WP2.1 Implement the quality management system (month 0-12) WP2.2 Notified body review of technical file and award of CE mark (month 6-18) WP2.3 FDA submission of 510(k) for United States product deployment. (month 2-24) Rationale: Regulatory approval (market clearance) is essential for clinical implementation, and a requirement for incorporation into OEM systems. FDA510(K) award will overcome a major commercial barrier for widespread adoption beyond the EU. Deliverable GIQuantTM CE mark WP3 Health Technology Assessment Objective: Establish cost-effectiveness of GIQuantTM and suitability for NHS supply chain. WP3.1 Collect detailed information on the costs of diagnosing and managing CD (month 0-6) WP3.2 Develop a cost-effectiveness model (month 0-21) WP3.3 To calculate the budgetary impact of GIQuantTM (month 12-24) WP3.4 Creation of user-friendly versions of the cost-effectiveness model (21-24) Rationale: GIQuantTM represents a capital outlay for the healthcare provider (likely &pound;50 per patient/scan) but would return immediate cost savings (&pound;100-300) by simplifying scan acquisition protocols. Through rationalised delivery of therapy, potential savings could range from hundreds to thousands of pounds per patient/year whilst improving patient care. UCLH has excellent financial records for its CD service as well as hosting two multi-centre CD studies allowing us to model GIQuantTM use in practice, building a robust health-economic case to present to the Central Commissioning Groups and stimulate NHS uptake. Deliverable: Cost and cost-effectiveness analysis plus budget impact study for the GIQuantTM service in the current clinical pathway. WP4 Implementation Objective: Fully implement GIQuantTM in the clinical setting. WP4.1 Establish route to market for GIQuantTM in the NHS (month 0-6) WP4.2 2 Implement GIQuantTM at UCLH (month 12-24) WP4.3 PPI engagement and dissemination (month 0-24). WP4.4 GIQuantTM deployment (18-24) Rationale: UCLH is one of the leading UK centres for CD management with internationally recognised expertise. Like other centres, it's looking to reduce growing CD related healthcare costs. Working with the divisional managers of Gastroenterology (Sara Shaw) and Imaging (Hugh Jelley) this work package will pilot clinical implementation of GIQuantTM at UCLH informed by cost-benefit data from WP3. A comprehensive assessment and successful integration of GIQuantTM at UCLH could stimulate uptake at other tertiary referral centres, ultimately precipitating wider NHS adoption. Deliverable: Clinical implementation of GIQuantTM at UCLH and deployment plan for the UK & Europe.

Lay abstract: Background: Crohn s disease (CD) is a painful, lifelong inflammatory condition of the bowel affecting 92,000 people in the UK. Medical management involves controlling inflammation with medication to improve symptoms and prevent long-term bowel damage. However patients without inflammation do not benefit from such medication and up to 40% of these people either do not respond or lose response. This makes ongoing treatment ineffective. The medications can cause severe side effects and are expensive costing &pound;400m/year in the UK. This represents around 2/3 of the CD healthcare cost. Clinical need: There is a need for a tool which can non-invasively detect and monitor bowel inflammation and also show if medication is working. If the new tool suggests that the patient's medication is not working they could quickly be given an alternative treatment. Proposed solution: Intestinal motility (contractions moving food through the gut) becomes abnormal in CD. Research has shown that if a drug therapy is working intestinal motility rapidly returns to normal. The technology company Motilent has developed GIQuantTM, an innovative software that allows objective and repeatable measurements of motility based on Magnetic Resonance Imaging (MRI) scans of the bowel. These scans are already routinely performed in the NHS. Motilent s technology could be integrated into the hospital without new equipment or intensive training. It could shorten the total scan time by up to 20 minutes and avoid contrast injections, reducing costs and improving patient experience.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: ORAL AND GASTROINTESTINAL