Periodic Reporting for period 2 - LUCA (Laser and Ultrasound Co-Analyzer for thyroid nodules)
Reporting period: 2017-08-01 to 2019-01-31
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.
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.