Prospective evaluation of an affordable and portable artificial intelligence-based modality for breast cancer screening in women across breast densities.

Abstract

e13585 Background: Mammography is known to be less effective in women with dense breast. Thermalytix is a radiation-free technique for breast screening which uses artificial intelligence over thermal images and has shown promising results in early clinical results. Methods: A prospective, cross-sectional study was conducted from December 2018 to January 2020 to compare the performance of Thermalytix with Mammography in women with dense and non-dense breast tissue. Women aged between 30 and 80 years who presented for a routine health check-up to the hospital and provided informed written consent for the study were included in the evaluation. All women took both Thermalytix and 2D-mammography tests. The output of the Thermalytix tool was blinded to the radiologist interpreting mammograms and the Thermalytix technician did not have access to any other imaging reports of the patient . For participants who were reported as positive on either or both of the tests, confirmatory diagnostic investigations were recommended; the outcome of which was used as the ground truth for comparison. Sensitivity and specificity of the two tests were calulated across age-groups, menopausal status, and breast densities.. Results: Among the 687 women invited for the study, 459 women fulfilled the inclusion criteria for the study analysis. Overall, 21 women were diagnosed with breast malignancies in the study. Thermalytix demonstrated an overall sensitivity of 95·24% (95% CI, 76·18-99·88) and a specificity of 88·58% (95% CI, 85·23-91·41). In 168 women (36·6%) who had ACR categories ‘c’ or ‘d’ dense breasts, Thermalytix showed a sensitivity of 100% (95% CI, 69·15-100) and specificity of 81·65% (95% CI, 74·72-87·35). Among these 168 women, 37 women had an incomplete assessment (BI-RADS 0) of their mammograms with a single reader (trained radiologist), while all 3 malignancies in these women were identified by Thermalytix tool. Conclusions: Thermalytix has the potential to be a radiation-free, privacy-conscious modality for breast cancer screening. Particularly in women with dense breast tissue, it can be a supplemental modality to mammography. As an automated, portable and affordable solution, Thermalytix test could be used alone for large-scale breast cancer screening programmes in resource-constrained settings. Clinical trial information: NCT04688086.