PRESS RELEASE: Approval for EUPHORIA's clinical trial to assess colon inflammation in patients with IBD
People with the chronic condition IBD undergo recurring phases of inflammation and remission of the gastrointestinal tract. In treatment management of IBD, it is necessary to closely monitor inflammatory activity of the bowel because therapy failure occurs in 30-50% of patients. Persistent inflammatory activity is related to higher complication rates, hospitalization, and cancer – all of which may be avoided by early adaptive treatment changes through improved disease monitoring.
In current care, colonoscopy is the gold standard in IBD diagnosis. However, this procedure poses a significant burden and complication risk on patients due to the need for bowel preparation and the invasiveness of the procedure. On the other hand, non-invasive procedures such as clinical examination and ultrasound imaging show high variability and diagnostic inaccuracy.
MSOT imaging is a new non-invasive diagnostic method based on the so-called photoacoustic effect – the conversion of light energy into sound waves. This technique combines pulsed laser excitation of tissue with ultrasound detection. Tissue – in this case the colon wall – absorbs the laser light energy and emits ultrasound signals. The signal amplitude correlates with the blood concentration in the colon wall, a biomarker of inflammation.
The goal of the EUPHORIA clinical trial is to assess the ability of MSOT as a tool to measure disease activity in people with Crohn’s Disease (CD) and Ulcerative Colitis (UC). The diagnostic performance of the MSOT Acuity Echo investigational device will be compared to colonoscopy and to other commonly used diagnostic procedures, such as MRI and ultrasound imaging as well as blood and fecal lab analyses. Lead Investigator Prof. Maximilian Waldner from the University Hospital Erlangen comments: ‘We are extremely excited to bring MSOT closer to clinical routine for IBD patients by validating the findings from our initial pilot trial.’
About iThera Medical
Since its incorporation in 2010, iThera Medical develops and markets optoacoustic imaging systems for preclinical and clinical research. More recently, the company has started translating its technology for routine diagnostic clinical use across various types of diseases, including cancer, inflammatory, fibrotic, and cardiovascular diseases. Optoacoustic imaging utilizes the photoacoustic effect – the conversion of light energy into acoustic signals – to visualize and quantify optical contrast in deep tissue, at high spatial and temporal resolution. For details see: www.ithera-medical.com
The EUPHORIA clinical trial is part of the EUPHORIA Project, an EU funded project which is led by iThera Medical. The Project also involves University Hospital Erlangen (Germany), IMASONIC SAS (France), Rayfos Ltd (UK) and Pintail Ltd (Ireland). EUPHORIA aims to optimize iThera Medical’s MSOT technology and test its efficacy in a large clinical study, generating evidence to support CE marking for the device, validating clinical utility and demonstrating benefits for IBD patients. During the project the partners will also explore potential health economic impacts and plans will be developed to bring this novel technology to the market-place and to the clinic. For details see: www.euphoria2020.eu
For further information, please contact:
Phone: +49 (0)89 700 7449-21
The EUPHORIA Project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 830965. The material presented and views expressed here are the responsibility of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out.
October 20th, 2020