#	Pagina
attuale pagina	/open-h2020/projects/220348/results.html

Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - EUPHORIA (Enhancing Ultrasound and PHOtoacoustics for Recognition of Intestinal Abnormalities)

Teaser

Summary

Inflammatory bowel disease (IBD) is a chronic condition, posing significant burden to patients and health care systems. Inflammatory bowel diseases (IBD), such as Crohnâ€™s disease and ulcerative colitis, are chronic conditions that affect more than 2.5 million people in Europe, posing significant burden to patients and health care systems. The total economic burden of IBD, including unemployment, sick leave and work disability costs, is estimated at â‚¬4.5-5.6 billion each year in Europe alone. There are treatments that can reduce disease symptoms and prevent severe complications, but a better way is needed to diagnose IBD and monitor inflammation during treatment. Endoscopy is currently the best method for diagnosis and monitoring, but it is an invasive, expensive procedure that cannot be used frequently. What is needed, is a non-invasive alternative to improve patient care and which leads to substantial healthcare savings.

EUPHORIA will meet this need by establishing Multispectral Optoacoustic Tomography (MSOT) as a widespread routine clinical tool for non-invasive monitoring of IBD. The project will enable technical improvements to iThera Medicalâ€™s MSOT technology that will increase the diagnostic potential beyond what has been shown in a first feasibility study and improve usability. A large clinical study in IBD patients will be conducted with the enhanced MSOT technology, generating evidence to support CE marking for the new device, validating the clinical utility of the technology to clinicians and healthcare payors, and demonstrating benefit for IBD patients.

This technology will greatly benefit patients and health care systems:
â€¢ patients â€“ by reducing risk of complications, improving quality of life through better treatment management and more convenient diagnostic care,
â€¢ physicians and hospitals â€“ by providing an easy and fast diagnostic method, suitable for office-based use that is cheaper, better for detecting inflammation and suitable for frequent follow-up,
â€¢ payors and healthcare systems â€“ by saving costs (reducing the number of costly endoscopies, stopping ineffective treatments earlier, etc.), enabling more efficient use of clinical expertise and facilities, and improving patient outcomes.

Work performed

During the first six months of the project, the main focus has been on further developing iTheraâ€™s existing MSOT technology to deliver a prototype device that will be used in the clinical study later in the project. iTheraâ€™s MSOT technology uses a special transducer placed on the skin and dedicated software to non-invasively generate an image of the intestine. An initial prototype device worked well in a feasibility study, but EUPHORIA includes work to enhance and improve the transducer and software. Partners iThera and Imasonic have worked together to develop new designs for the transducer and investigated new coating materials to improve the images. Transducer prototypes based on advances achieved during the project are now under development and will soon be tested.

In parallel, partners iThera and RAYFOS have collaborated to improve the processing software and associated hardware, focusing on improving the reconstruction of optoacoustic and ultrasound information from the transducer into an image for use by clinicians in monitoring IBD. Industry standards for this type of imaging process have been identified and are now being integrated in the image rendering, priming the technology for widespread commercial adoption. The software is also being adapted to meet the requirements of clinicians and other end-users, as well as to align the final product with common medical imaging protocols and provide safe archiving.

In parallel with the technology development, iThera and the University Hospital Erlangen are preparing for the clinical study. Extensive input on the study design has been sought from external experts, including world-leading clinicians, reimbursement and market access consultants, contract research organisations that manage clinical trials and a patient representative. These inputs have been used to develop the study design. The team has also had positive discussions with the notified body that will evaluate if the device is ready for market access.

Given the commercial focus of the project, careful management of the intellectual property and strategic commercial planning are a key, overarching element that will ensure we fully achieve the expected impacts of the project. Notably, during interviews with clinician groups and healthcare delivery organisations, a new target group for the MSOT device was identified, i.e. pharma companies conducting clinical trials for new drugs in the indication of IBD. iThera filed two patents relevant for the MSOT technology being developed for EUPHORIA just prior to the project start, and patenting of two new developments from the transducer optimisation activities is under investigation by Imasonic.

Final results

The MSOT technology developed during EUPHORIA promises to greatly benefit patients and health care systems. For patients, non-invasive MSOT monitoring of IBD will reduce the risk of complications, and improve quality of life through better treatment management and more convenient diagnostic care. Physicians and hospitals will benefit from an easy and fast diagnostic method, suitable for office-based use that is cheaper and better for detecting inflammation than current methods, as well as being suitable for frequent follow-up. Adoption of MSOT technology will save costs for payors and healthcare systems by replacing costly endoscopy and stopping ineffective treatments earlier. The technology will also enable more efficient use of clinical expertise and facilities, and improve patient outcomes.

Developments to iTheraâ€™s MSOT technology that will advance the state-of-the-art in non-invasive diagnostic imaging have been the focus of the first six months of the project. In the first six months of the project, MSOT technology advances have been the focus of the project. To this end, optimisation work on the ultrasound transducer to enable better imaging performance and suppression of artefacts was carried out. On the software side, updates will improve usability, enable faster image reconstruction and increase compatibility with clinical image systems.

The EUPHORIA team has also been actively engaging with key stakeholders, including patients, clinicians and other experts, focusing on building awareness of the technology and preparing for commercialisation activities. For example, the project has been presented at European event (e.g. European Crohnâ€™s and Colitis Organization Congress) and has joined the social media conversation around important IBD events (e.g. World IBD Day).