A Prospective Observational Study to evaluate the Clinical Performance of Thermalytix against Standard Breast Imaging Modalities for detecting breast malignancies in asymptomatic and symptomatic women.

The proposed study is a comprehensive, prospective cohort study aiming to evaluate the efficacy of Thermalytix, a novel AI-based diagnostic tool, in comparison to the standard of care breast imaging modalities for detecting suspicious breast lesions among both asymptomatic and symptomatic women aged 30-80 years. The study will take place at Breast Services Clinic, Department of General Surgery, Seth GSMC and KEM Hospital, Mumbai, and follows a meticulously structured protocol. Prior to imaging procedures, CHVs will engage with the local population as a part of their routine job and will disseminate the details of the BMC breast screening centers in BMC offices. The imaging phase comprises two-view screening mammography and whole breast ultrasound, conducted by trained radiologists at designated centers. The results are graded on the BIRADS scale, with BIRADS 1 and 2 participants not proceeding to the next phase. Participants with BIRADS 3, 4, or 5 results undergo histopathology at KEM Hospital following clinical examination. The study also encompasses the assessment of Thermalytix’s feasibility for population screening, gauging patient experiences in comparison to standard imaging modalities, and collecting demographic data to better understand the affected population. This study design, with its comprehensive approach to breast health screening, follows established medical practices for breast cancer diagnosis and offers a holistic evaluation of novel diagnostic technology’s potential impact in a real-world setting.