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.
