BRIDGING THE GAP BETWEEN ACADEMIA & CLINICAL TRIALS FOR THE DEVELOPMENT OF RARE DISEASE TREATMENTS VIA NUCLEAR MAGNETIC RESONANCE IMAGING (MRI)

Projektinformationen

RD-MRI NETWORK

ID Finanzhilfevereinbarung: 888341

DOI

10.3030/888341

Projekt abgeschlossen

EK-Unterschriftsdatum 2 Dezember 2019

Startdatum 1 Januar 2020

Enddatum 31 Mai 2020

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

CONSULTANTS FOR RESEARCH IN IMAGING AND SPECTROSCOPY SCRL
Belgium

Periodic Reporting for period 1 - RD-MRI NETWORK (BRIDGING THE GAP BETWEEN ACADEMIA & CLINICAL TRIALS FOR THE DEVELOPMENT OF RARE DISEASE TREATMENTS VIA NUCLEAR MAGNETIC RESONANCE IMAGING (MRI))

Berichtszeitraum: 2020-01-01 bis 2020-05-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

The RD-MRI network project aims at promoting the use of imaging, and more specifically magnetic resonance imaging (MRI), as an outcome measure for the evaluation of novel therapies in rare disorders. Rare disorders (RD) are by definition rare but they are so numerous that up to 30 millions of patients are affected by RD in the European Union. More and more innovative therapeutic options for RD are being introduced and they need to be carefully evaluated, preferably with non-invasive tools. Quantitative MRI is extremely performant to achieve this goal. First, the RD-MRI network will connect clinical sites and offer expertise and tools to implement protocols and processes for RD monitoring and evaluation with imaging solutions. Second, the network will propose highly specialized services to the pharmaceutical industry. It will enable the industrial partners to use MRI as a secondary or even as a primary outcome in multicentre clinical trials with solutions tailored to their needs while being fully compliant with regulations.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

An extensive search was conducted to identify RD with an incidence/prevalence high enough for the organization of a multicentre trial and with pathological features that could be monitored by imagery, and in particular the imaging tools available in the network. For this selection of RD, almost one thousand on-going interventional phase 2 trials were counted and more than two hundred drugs with orphan designation are registered. All these data confirmed the existence of a vast market for the use of imaging as an outcome in RD.
The development of a proprietary data management environment was pursued and a prototype is currently being tested. A web service for academic collaboration has been installed and is ready to be used. Unique artificial intelligence based processing tools have been validated and will be incorporated in the network portfolio.
Based on the market size and potential growth, a recruitment plan was established and financial estimates have confirmed the viability of RD-MRI network.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

The RD-MRI network will promote a unique multi-level collaboration between pharmaceutical industry, clinical research and academic teams specialized in imaging methodology, signal processing and artificial intelligence. The long-term objective is to shorten the therapeutic development cycle through early non-invasive demonstration of efficacy with imaging outcome measures. The same tools might facilitate the generalization of precision medicine, with a direct impact on the management of millions of RD patients.