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Multimodal highly-sensitive PhotonICs endoscope for improved in-vivo COLOn Cancer diagnosis and clinical decision support

Periodic Reporting for period 1 - PICCOLO (Multimodal highly-sensitive PhotonICs endoscope for improved in-vivo COLOn Cancer diagnosis and clinical decision support)

Reporting period: 2017-01-01 to 2018-06-30

The main objective of the project is the development of a fully-functional wide-field fluorescence based, OCT and MPT photonics endoscope for improving colorectal cancer diagnosis providing in-vivo image-guided biopsy capabilities and higher sensitivity and specificity than current diagnostic methods.

The main objectives of the project and the work carried out during the reporting period are:
Objectives:
Obtain unprecedented sensitivity and specificity (>99%, >95%) on the optical analysis of neoplastic colorectal lesions.
Reduce by 40% the needs of biopsying of the polyps detected on a colonoscopy.
Reduce the number of missed polyps by 30% including the most challenging flat lesions.
Reduce re-interventions by 90% by assessing lesion infiltration and resection assessment in situ.
Reduce the intervention costs by 30% per patient outcome.
Facilitate and augment the presence of EU Photonics SMEs and companies into the demanding biomedical diagnosis market via the exploitation of the PICCOLO endoscope and its components.

Work carried out during reporting period towards achievement:
Use of complementary high-resolution OCT and MPT techniques.
Generation of a high-quality database for imaging biomarkers extraction.
Include a new detected use case for wide field polyp detection automatic detection based on image analysis that focus on flat polyps through the analysis of micro-texture.
Focus on the analysis of different fluorescence analysis.
Verification due clinical questionnaires on the importance of this need
Clinical needs, system requirements and system design already cover this requirement that involves minimum tolerable acquisition depth.
WP3 imaging dataset acquisition already consider acquiring images after sucessive resection to train the model detect clean tissue.
PEDR and Pre-exploitation plan already consider several exploitation channels.
Project SMEs have positioned themselves as component provider for this and other biomedical use cases and STORZ will be able to facilitate market entrance by integrating project ERs.
The project started its activities establishing management rules and procedures to be followed within PICCOLO project that rapidly dealt on the establishment of the project governance structure and management plan.
WP1 was the starting technical WP and it established the clinical and market needs and their respective use cases that allowed the definition of the functional and non-functional requirements of the project. These requirements help establishing the first high level design of the PICCOLO system that supported the works of the other technical WPs.
In parallel, WP7 appropriately handled ethical and regulatory issues: Ethical approval for both animal and clinical research within PICCOLO were requested and approval was granted. On the other hand, a regulatory roadmap assuring both safety and efficiency to be fulfilled under PICCOLO project has been agreed among the different partners. All the necessary protocol for the studies to be carried out in the hospitals have been performed as well as as well as the elaboration of the Data Management Plan (DMP) that includes a risk assessment report, key documents for the development of the PICCOLO Project.
WP2 started the development of the different photonics components, 1) OCT laser sweep 2) MPT Ti:Sapphire laser 3) Endoscope imaging system that will be combined by WP4. These components were produced. However technical complications and electro-optical failures during system integration caused a delay on the OCT component. This issue was deeply and seriously discussed under several ordinary and extraordinary meetings as it would have implied to proceed onto the animal and human tests without part of the imaging modalities. This would have implied that all acquisition effort in WP5 (animal tests, disease stratification acquisition, comparative histology analysis), WP6 (human validation) and WP3 (imaging database, imaging biomarkers) would have been performed only for MPT imaging. Based on this consideration, project consortium managed to re-schedule animal trials to adapt to the new situation which was not an easy task as it involved already scheduled animal individuals.
WP4 has designed and implemented the first version of the scanning system. The integrated optical coupler has been set up and tested for the MPT laser source, and is ready to be tested for OCT. MPT and OCT subsystems, including revelation electronics and LabVIEW acquisition software, have been realized.
At WP5, driven by regulatory requirements, animal tests have been already defined. Unforeseen ROS analysis and long-term tissue damage essays have been also included to assure that a harmless device is designed. The validation plan on animal models has been defined, detailing and scheduling all the animal tests that will be performed within PICCOLO project. WP6 has performed preparatory activities and human videos from wide field colonoscopies are being acquired.
WP3 has successfully deployed the data server and access contract and security protocols have been defined and agreed. The database generation protocols have been carefully designed involving all actors to allow a high-quality annotated imaging dataset that will be made accessible to the community after project time.
The exploitation and dissemination activities are tackled by WP8. Continuous monitoring and streamlining of the efforts to the needs, requests and information of the market was guaranteed by the guideline document PEDR (D8.1) whereas continuous technology and market observation is periodically updated (D8.8). The pre-exploitation plan was delivered at M18 including the exploitation strategy plans for the whole system and the individual exploitable results. Web page and project twitter accounts were created as well as the first public material and public presentations both for the general public and for the medical community.
Project coordination was driven by WP9 and has successfully set all the technical, administrative and financial
Having into consideration the objectives of the project, the foreseen exploitable results are:

Category - PICCOLO Exploitable Result (ER)
1. Diagnosis imaging tool and technology - Hybrid fluorescence, OCT and MPT multimodal biophotonics endoscope ER1
2. Photonics technologies - Ultrafast MPT/OCT scanning system ER2
Miniaturized OCT system ER3
Ti:Sa laser source ER4
3. Software tools for diagnosis - Computer Aided Diagnosis (CAD) Software for Colon lesions risk assessment ER5
4. Methodologies and new knowledge -Imaging biomarkers and digital tumoral models ER6
OCT/MPT imaging database ER7

The different ER have been prioritized and a highly detailed level individual exploitation plans have been done for each of them. This is described in more detail on the description of WP8 activities in this report.
Patients Leaflet, Side A
Project Leaflet, Side A
Patients Leaflet, Side B
Project Leaflet, Side B