Evaluating Clinical Efficacy of Thermalytix As a Breast Cancer Screening Tool in Young Women

Abstract Objective: Breast cancer remains a significant health challenge worldwide, particularly among women under 45 years of age who often present with dense breast tissue. Mammography, the current gold standard for breast cancer screening, is less effective in this demographic due to reduced sensitivity in detecting malignancies within dense breast tissue. This study evaluates the efficacy of Thermalytix, an artificial intelligence-driven, noninvasive, and radiation-free thermal imaging tool, as a screening modality for breast cancer in young women through a meta-analysis of published studies. Materials and Methods: This meta-analysis aggregated the data from three clinical studies involving a total of 1187 women who first underwent a Thermalytix test followed by reference standard of care (SoC) tests, which included one or more mammography, ultrasound, and biopsy. Among these women, 463 were under 45 years of age and were eligible for this study. Thermalytix analyzed high-resolution thermal images of the breast, utilizing novel radiomic features such as hotspots, vascular patterns, and areolar characteristics to predict malignancy. The performance of Thermalytix was evaluated by computing its sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), with 95% confidence intervals (95% CIs), in both the overall population and the younger cohort by aggregating the data from all studies. Results: Among the 463 young women under 45 years, 43 were diagnosed with breast cancer as per SoC. When raw data were aggregated from this young women cohort, Thermalytix resulted in a sensitivity of 90.7% (95% CI: 82.0%–99.4%), a specificity of 82.1% (95% CI: 78.5%–85.8%), a PPV of 34.2% (95% CI: 25.5%–42.9%), and an NPV of 98.9% (95% CI: 97.7%–100%). The pooled sensitivity and specificity of Thermalytix using the random-effects model were estimated to be 96.0% (95% CI: 88.9%–100%) and 82.3% (95% CI: 78.6%–85.9%), respectively. Further, in the entire population of 1187, Thermalytix showed an aggregated sensitivity of 88.3% (95% CI: 83.3%–93.2%), specificity of 84.7% (95% CI: 82.5%–86.9%), PPV of 47.7% (95% CI: 42.0%–53.3%), and NPV 97.9% (95% CI: 96.9%–98.8%). Conclusions: Thermalytix demonstrated high sensitivity and NPV in women under 45 years of age, suggesting its potential as an effective screening modality for younger women who face challenges with conventional screening methods due to dense breast tissue.