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Laser and Ultrasound Co-Analyzer for thyroid nodules

Periodic Reporting for period 3 - LUCA (Laser and Ultrasound Co-Analyzer for thyroid nodules)

Reporting period: 2019-02-01 to 2021-05-31

Thyroid nodules are a common pathology having a prevalence of 19-76% when screened with ultrasound, with higher frequencies in women. Current medical methods used to assess the malignancy of a nodule consist in performing an ultrasound, followed by a Doppler ultrasound, and then a biopsy. However, unfortunately, these methods present both low specificity and low sensitivity. This insufficient effectiveness in accurately being able to diagnose thyroid tumors leads to many unclear or unnoticed cases as well as many others that undergo unnecessary surgeries (false positives) and increase the cost of medical healthcare, not to mention the reduction of quality of life of patients.
The EU-funded project Laser and Ultrasound Co-analyzer for Thyroid Nodules (LUCA), running from 2016 to 2021, worked on the development of a new near-infrared optical device combined with clinical ultrasound. The goal of the LUCA project was to provide this platform for testing on patients undergoing screening for thyroid cancer with the ultimate aim that this enhanced information will provide better and more specific results in thyroid nodule screening.
In particular, the LUCA device combined near-infrared time resolved spectroscopy (TRS) and diffuse correlation spectroscopy (DCS) with the clinical norm, i.e. the ultrasound that is used on thousands of patients every year for screening thyroid nodules for malignancy. The two optical modules enabled the characterization of the vascularization, the consumption of oxygen and structural changes of the nodules while being guided by the ultrasound images to be pointed at the right position. Other more novel biomarkers such as the collagen, lipid and thyroid specific light absorbers were also tested.
The project covered all aspects of this development starting from independent modules that were not cost-effective. The partners worked on developing cost-effective sub-systems for light generation, delivery, detection, and processing. They developed an ergonomic multi-modal probe built around a commercial ultrasound probe. Also, they developed tools for standardization, characterization, and calibration. Finally, these were put together in a research platform coupled with an advanced parameter recovery and modeling engine which was submitted for approvals from the authorities. Once the approvals were obtained, the LUCA platform was installed at the clinic for brief clinical studies.
At the end of the project, the platform was tested on a group of healthy (18) volunteers and patients (47) who had nodules and were scheduled for thyroidectomy. The LUCA device showed potential for identifying a particular group of nodules as benign or malignant which were stipulated as being unclear cases with the classical ultrasound screening technique. By analyzing the metabolic rate of oxygen consumption and total hemoglobin concentration, the device was able to classify thirteen benign and four malignant nodules that fell in this group with a sensitivity of 100% and specificity of 77%.
Currently, the system remains in the clinics and is being tested on additional subjects. Other areas of potential application are also examined and ethical approvals were requested.
The next steps for the LUCA platform and the partners involve seeking funds for continuation of more extended clinical trials, the industrialization of the platform by the commercial partners for introduction into the markets and the commercial and scientific exploitation of the developed sub-systems, modules, and methods.
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 new components for DCS and TRS modalities that offer drastic reduction in production costs, charted out and tested inter-operability and compatibility of the three modalities. This was 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 and at the start of Phase 3 (M30-M64) the key technical goal was 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, tested and moved to the clinic for the clinical studies. During clinical validation (Phase 3), the platform was tested on 18 healthy volunteers and 47 patients with nodules scheduled for thyroidectomy. The clinical study showed that the LUCA device has the potential to discriminate between benign and malignant thyroid nodules which were determined unclear cases using conventional techniques.
Throughout the project, efforts in exploitation and dissemination continued. We reached out to different stakeholder communities and general audiences via social media, print media, radio and TV, scientific publications and at fairs and conferences. 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 addressed the question by what method this could be achieved. As a multi-disciplinary, crosscutting project LUCA pushed 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 thyroid cancer screening is innovative and only enabled by this proposed combination of developments in components, sub-systems, and devices. We addressed the shortcomings in thyroid nodule screening leading to an excessive number of unnecessary biopsies and surgeries with a severe socio-economic impact. Our ambition was to contribute to a major leap in thyroid cancer screening enabling early and faster diagnosis. Overall, the LUCA project allowed us to develop a unique optical-ultrasound platform which we are confident will find a use in clinical thyroid cancer screening saving millions of euros over the coming decades and improving the lives of millions of Europeans.
The potential applications of LUCA go beyond the thyroid 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 companies to increase their product portfolios for components for diffuse optical devices, for stand-alone systems and with the multi-modular LUCA system.