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Laser and Ultrasound Co-Analyzer for thyroid nodules

Periodic Reporting for period 2 - LUCA (Laser and Ultrasound Co-Analyzer for thyroid nodules)

Reporting period: 2017-08-01 to 2019-01-31

The screening of thyroid nodules for cancer is a major health concern with e.g. a single hospital in metropolitan Barcelona area (IDIBAPS/Hospital Clinic Barcelona) reporting more than 3500 thyroid screenings per year. The goal of the screening is to identify high-risk nodules for malignancy, i.e. cancer, for further, more invasive evaluation and potentially surgical intervention, and to avoid missing any malignant nodules. As the sensitivity and specificity of the current screening methods are limited a large number of non-diagnostic and/or false positive biopsy results (about 750,000/year in Europe) lead to unnecessary surgeries (about 150.000/year in Europe). A reduction in their number by a diagnostic procedure that permits to better distinguish between benign and malignant nodules would have an important socio-economic impact, diminishing the number of thyroidectomies and associated comorbidities. Diffuse optical technologies are well tested for other applications including the discrimination of tumours/nodules as benign or malignant.

LUCA is a trans-disciplinary 4-year project that joins endocrinologists (“end-users”), radiologists (“end-users”), physicists (experts in medical photonics), engineers (experts in photonics and ultrasonics), and industry partners. The overall goal is to produce a novel, point-of-care, low-cost, screening device that combines two photonics systems (near-infrared diffuse correlation spectroscopy (DCS) and time-resolved spectroscopy (TRS)) with a clinical ultrasound (US) system and a probe that enables multi-modal data acquisition for the screening of thyroid nodules. The multi-modal approach that includes hemodynamic and structural information will lead to better specificity while each modality on its own fails. A new optical-ultrasound probe and an integrated system enabled by the development of novel, key enabling photonic components and sub-systems to provide synergetic information on tissue morphology, composition and function will have a large impact in this field reducing the number of unspecific biopsies and unnecessary surgeries. LUCA started at a technology readiness level (TRL) of 5 and will evolve to a TRL of 7.

The project has now completed its first 3 years. The main accomplishment of this period was the development and construction of the LUCA demonstrator: a prototype that has been thoroughly tested and validated against laboratory standards in preliminary sessions on healthy volunteers and has recently been translated to the clinic for the clinical studies in the final project year. The road to this involved the development of new components (lasers, detectors, electronics) for TRS and DCS, a combined optical US probe, new analysis methods, and a corresponding software suite and protocols for the control and communication of different modalities. These were tested and validated ex vivo on phantoms and standards and translated into new clinical protocols for validation in real-settings. The aims and progress of the project were widely disseminated and communicated to all target groups, detailed exploitation plans were made for the side products (e.g. individual components) and for the ultimate multi-modal LUCA system and ethical approvals were received. We are now entering the final phase of the project in which we will validate the usability of the LUCA device and obtain pilot data to evaluate its potential for thyroid cancer screening.
We are now reporting the progress from the first 36 months of this 48-month project. During Phase 1 of the project (M1-M18) and the onset of Phase 2 (M12-18), apart from setting up the management structure of the project, most of the work focused on the development of components and sub-systems as well as on the development of the project exploitation plan. This important phase was completed leading to novel new components for both DCS and TRS modalities that offer drastic reduction in production costs, charted out and tested inter-operability and compatibility of the three modalities. These were all done in conjunction with extensive laboratory testing, preparation of the clinical protocols, dissemination and communication of the project and its progress while keeping in mind the ultimate goal of clinical and market translation.

Throughout Phase 2 (M12-M36) and since the start of Phase 3 (M30-M48) the key technical goal has been to complete the LUCA prototype demonstrator, test and validate it in laboratory tests, obtain the ethical approvals and prepare for the start of the clinical studies. The tasks in component, sub-module, module development and testing were merged with integration tasks with teams working closely together. The prototype was completed and tested and has recently been moved to the clinic for the clinical studies. We have now entered the final, exciting phase of clinical evaluation.

At the same time, efforts in exploitation and dissemination continued. We have reached out to different stakeholder communities and general audiences via social media, print media, radio and TV, scientific publications and at fairs and conferences. We are happy to report that the LUCA project is well received. For exploitation and optimal impact, targeted actions were taken and alliances formed. One important outcome was that LUCA could impact other fields in healthcare (e.g. oncology, rheumatology, paediatric neurology and nephrology) and we will now explore these and other (e.g. veterinary medicine) possibilities further.
In Europe, there are approximately 130 million adults living with thyroid nodules based on the estimates from the latest screening statistics. About 2% (2.6 million) of these people will receive fine needle aspiration biopsy as a result of their screening leading to about 800,000 indeterminate or non-diagnostic biopsy results. This will lead to 150,000 surgeries that could be avoided. LUCA addresses the question by what method this could be achieved. LUCA is a multi-disciplinary, crosscutting project that pushes beyond the state-of-the-art in (1) diffuse optical technologies for biomedicine and (2) the screening of thyroid nodules for cancer. The concept of utilizing a combined optical-ultrasound probe for the screening of thyroid cancer is innovative that is only enabled by this proposed combination of developments in components, sub-systems and devices. We address the shortcomings in the screening of the thyroid nodules that lead to an excessive amount of unnecessary biopsies and surgeries with a severe socio-economic impact. Our ambition is to achieve a major leap in thyroid cancer screening, which will enable early and faster diagnosis to save millions of euros over the coming decades and to improve the lives of millions of Europeans. The potential applications of LUCA go beyond thyroid screening into other areas of cancer screening or even other types of diagnosis where the combination of diffuse optics and ultrasound can be beneficial. This in turn provides advantages for the participating SMEs in increasing their product portfolios for components for diffuse optical devices, for stand-alone systems and with the multi-modular LUCA system. LUCA will also explore other application areas.