(1) Background: Breast cancer screening remains limited by mammography, particularly in younger women, in dense breast tissue, and in the detection of interval cancers. The PHI-BRA Smart Bra was developed as a wearable, non-invasive device combining thermography and bioimpedance for frequent breast monitoring. This first-in-human study aimed to assess the feasibility and in vivo diagnostic performance of the PHI-BRA system in discriminating between women with and without breast lesions. (2) Methods: A prospective feasibility study was conducted between March 2023 and February 2024. A calibration cohort (n = 15) was used to define the discrimination model, followed by an analysis cohort (n = 26; 13 with breast lesions and 13 without). Thermal and bioimpedance signals were acquired using the PHI-BRA device. Diagnostic performance was evaluated using receiver operating characteristic (ROC) analysis, with mammography as the reference standard. (3) Results: In the analysis cohort, the temperature-based model achieved an area under the ROC curve (AUC) of 80.8% (95% CI 63.2–98.3). At the optimal threshold, sensitivity was 84.6% (95% CI 61.5–100) and specificity was 76.9% (95% CI 53.8–100). Exploratory bioimpedance analyses showed lower sensitivity but high specificity, mainly limited by sensor contact stability. No adverse events were reported. (4) Conclusions: This first-in-human study demonstrates an initial exploration of the feasibility and safety of a wearable thermography-based approach for breast lesion discrimination. The results support further clinical validation of a multimodal wearable system as a complementary tool to existing breast cancer screening strategies.
Belmont et al. (Mon,) studied this question.
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