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Point-of-care instrument for diagnosis and image-guided intervention of Colo-Rectal Cancer

Periodic Reporting for period 3 - PROSCOPE (Point-of-care instrument for diagnosis and image-guided intervention of Colo-Rectal Cancer)

Reporting period: 2023-01-01 to 2023-12-31

The PROSCOPE project is driven by unmet clinical needs in the field of gastroenterological diagnosis and a clear business case. A novel optical imaging platform, which offers the potential to vastly improve early diagnosis of CRC by achieving specificity and sensitivity above 90%, to reduce the number of excisional biopsies by 50%, and to improve interval screening planning. Combined, all these advantages will benefit patients and reduce healthcare costs drastically. The consortium includes five leading academics, including hospital clinics, and four SMEs covering the entire value chain.

Colorectal cancer (CRC) is the second most common cause of cancer death in Europe, but survival rates drop dramatically if it is not detected early. One obstacle for early detection is that current colonoscopy, i.e. white light video or optical narrow band imaging, is inadequate for in-vivo detection and characterisation of the various types of (pre-)cancerous lesions found in the colon. Point-of-care, real-time polyp diagnosis and image-guided intervention has the potential to save lives and healthcare costs by enabling early onset of treatment. This will, in turn, reduce recurrence rate, improve and reduce the need for interval screening, and reduce pathology costs incurred during colonoscopy.
A complete, reliable optical diagnosis would need to be sensitive to both morphological and biochemical changes. Unfortunately, no single optical method provides both. PROSCOPE is designed to provide a unique combination of label-free, non-ionizing, proven optical imaging modalities that provide superior sensitivity and specificity compared to current colonoscopy, which will facilitate a step-change in point-of-care management of CRC.

With the PROSCOPE project, we aim to develop and integrate recent advances in optical imaging and optical probe technology into one platform. The concept will be validated in clinical settings using existing endoscopes that provide a minimally invasive optical imaging that can be incorporated into current clinical procedures. Leading medical device manufacturers and clinicians will be involved at every stage of the development and validation.
Before development of medical devices can begin, a so-called requirements engineering file is developed. This document serves as the basis for the entire development, and includes end-user, normative and regulatory requirements, as well as the function of the system and sub-systems of PROSCOPE.

The PROSCOPE project entails development of two optical probes: 1) a multimodal, endoscopic imaging platform that combines OCT and Raman spectroscopy enabling high-speed three-dimensional morphological as well as molecular analysis. Therefore, key tasks are targeting the realization of an OCT engine capable of accessing penetration depth of colorectal lesions, as well as the realization of a Raman spectroscopy system for molecular analysis; and 2) a light sheet two-photon probe for metabolic information. We have designed both probe head geometry, identified laser and delivery fibre specifications, and conducted first benchtop test imaging. These two clinical-grade endomicroscopy probes are to be applied through endoscopes and flexible arms, and definition of the design specifications, numerical and experimental evaluation of various opto-mechanical imaging concepts, and development of simulation and manufacturing/packaging techniques essential for the probe implementation has progressed well. As compliance with MDR is paramount, risk assessment and documentation has taken considerable efforts. Links have been established to relevant international standardisation bodies (ISO).

We have also continued preparations for obtaining ethics approvals for our studies, covering all modalities as well as ex vivo and in vivo human studies.
At the technical level, the project is in the phase of verifying and testing designs, in accordance with plans, and, in general, confirming our initial specifications. The progress is generally considered good, and our tests of the developed equipment show very good outcome. In addition, we have good progress on developing the therapeutic devices.

The PROSCOPE project and consortium has been designed to maximise the impact of our results and outputs, and to provide a foundation for wider European work in this field in the future. All key technical elements of the project have been put in place (visual identity, online, communications strategy) and work continues to determine the health and economic benefits to Europe of faster diagnosis and treatment of CRC. While most dissemination work will be concentrated late in the project when scientific outputs can be published, we held a successful briefing at the European Parliament on some specific outcomes and the general role of optical imaging being an effective tool in combating cancer.
PROSCOPE InfoGraphics