Medical device company iThera Medical announces that the second site in Germany has been initiated for the ongoing clinical study in the EU-funded Horizon 2020 project EUPHORIA. The project aims to further develop the company’s proprietary optoacoustic imaging technology and demonstrate its clinical value in the assessment of inflammatory bowel disease (IBD).
The chronic condition IBD is marked by recurring phases of inflammation and remission of the gastrointestinal tract. With adequate treatment, the symptoms of the disease can be effectively managed for many patients to help improve their quality of life. However, it is necessary to closely monitor inflammatory activity of the bowel throughout treatment management, as therapy failure occurs in 30-50 percent of patients.
Currently, the gold standard in IBD diagnosis and monitoring is endoscopy to examine the bowel wall. Due to the inherent invasiveness of the procedure and the need for bowel preparation and sedation, endoscopy poses a significant burden for patients in addition to a risk of complications. A non-invasive alternative means of assessment could allow for more frequent monitoring – and thus improve clinical understanding of disease status and choice of therapy.
Multispectral Optoacoustic Tomography (MSOT) is a recently-developed diagnostic imaging method based on the conversion of light energy into sound waves – also known as the photoacoustic effect. This technique combines pulsed laser excitation of tissue with ultrasound detection to allow non-invasive assessment of inflammation in the bowel wall. Through previous pilot studies, MSOT has already demonstrated its clinical value in IBD, where the technology may offer an effective alternative to endoscopy to monitor disease status.
The €2.3 million Horizon 2020 research project EUPHORIA (Enhancing Ultrasound and PHOtoacoustics for Recognition of Intestinal Abnormalities) led by iThera Medical aims to assess the ability of MSOT to measure disease activity in patients with IBD. Clinical validation of the diagnostic performance of the MSOT Acuity Echo investigational device is underway in a multicenter international study, with the Jena University Hospital (JUH) now added as the latest initiated site and the second site in Germany. JUH has already enrolled and successfully scanned the first patients with the MSOT Acuity Echo device. Two additional sites in Italy are slated for initiation in the coming weeks, with the project leaders expecting these sites to open within Q4/2021.
The initiation of new study sites will allow for faster patient recruitment to acquire data necessary for the clinical validation of the MSOT technology in the application of disease monitoring in IBD. Furthermore, iThera Medical will use the feedback from the various patient and investigator groups to guide the ongoing development of the MSOT technology to best benefit doctors and their patients.
Prof. Dr. Andreas Stallmach, Director of the Clinic for Internal Medicine IV at JUH, and EUPHORIA’s principal investigator at the Jena study site, expresses his enthusiasm for taking part in the study: “We are excited to be part of this groundbreaking clinical study, which will assess a very promising and non-invasive new technology for IBD inflammatory status monitoring.”
EUPHORIA marks a key step towards establishing MSOT as a competitor in the broader medical imaging market and offering a better way to monitor IBD.
For more information on the EUPHORIA project, visit: www.euphoria2020.eu.
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 Project has received funding from the European Union’s Horizon 2020 research and innovation program 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.
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