Development of a skin cancer diagnosis device using active thermography

• Grant number: 23/16892-0
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: May 01, 2024
• End date: April 30, 2026
• Field of knowledge: Engineering - Biomedical Engineering - Bioengineering
• Principal Investigator: Fernando Costa Malheiros
• Grantee: Fernando Costa Malheiros
• Company: Subiter Diagnósticos por Imagem Ltda
• CNAE: Testes e análises técnicas ; Atividades de serviços de complementação diagnóstica e terapêutica
• Associated researchers: Jose Jeronimo Rabelo Faria ; Pedro Noronha Fagundes
• Associated research grant: 22/08103-2 - Active thermography and image segmentation for skin cancer diagnosis., AP.PIPE
• Associated scholarship(s): 25/06391-9 - Technical training in organizing and structuring clinical trials., BP.TT; 25/05120-1 - Back-end development of device software, BP.TT; 24/09897-8 - Back-end development of device software, BP.TT; + associated scholarships 24/07067-8 - Technical training in user interface and software/hardware integration, BP.TT; 24/10712-2 - Technical training in organizing and structuring clinical trials., BP.TT; 24/09579-6 - Front-end development of device software., BP.TT; 24/07009-8 - Technical training in software development, computer vision and image processing, BP.TT; 24/06999-4 - Training in collecting scientific data and technical information., BP.TT; 24/06983-0 - Development of a skin cancer diagnosis device using active thermography, BP.PIPE - associated scholarships

Abstract

The project proposal presented to FAPESP within the scope of the PIPE Phase 1 aimed to use active thermography and image segmentation to diagnose skin cancer. The following research question was posed: is it possible to classify a suspicious skin lesion as cancer or non-cancerous using active thermography and image processing techniques? In order to answer this question, the team conducted a vast literature review; carried out a large number of computer simulations of the thermal problem behavior; developed an examination protocol; developed image processing algorithms that define whether a lesion is cancer or not based on protocol images; built an experimental setup to apply the exam protocol; developed a computer user interface to operate the experimental setup and perform the examination; and, finally, carried out a clinical trial at the Barretos Cancer Hospital. The results of applying the examination protocol in clinical trials have validated that thermography, in combination with image processing strategies, is capable of classifying a suspicious skin lesion as cancer or not. In addition, the company has already signed a research cooperation agreement with the Barretos Cancer Hospital and the Lauro de Souza Lima Institute (ILSL) to carry out additional clinical trials.The next step in the development of the project is the construction of a dedicated device for diagnosing skin cancer that uses the examination protocol developed in Phase 1. Furthermore, it is necessary to further develop the image processing algorithms and software. The new software will have additional features to archive, organize and process images, operate the device and enable the healthcare professional to issue a report.Also, during the PIPE Phase 1, the team participated in the PIPE Entrepreneur Program Cycle 24, during which they had workshops and mentoring, developed a map of the business value chain, interviewed more than 100 stakeholders, among other activities. Such participation and other customer discovery actions enabled the team to understand a common path for health and bio techs regarding specific regulations and routines for product development. In this context, this project includes activities involving Intellectual Property (IP) protection, regulation with ANVISA and clinical trials of the complete solution (device and software). It is expected that the Technology Readiness Level (TRL) will be elevated from TRL4 to TRL6, possibly reaching TRL7, considering that the technology will be validated in a hospital environment.From a business perspective, after obtaining a license for commercialization from the regulatory agency (ANVISA), the company foresees revenue in two ways. One is licensing the image processing and storage software as a standalone solution, that can be used with different image sources, such as dermoscopy. The other is making the solution (device and software) available to professionals and charging per exam performed. (AU)