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This first-in-human study evaluates PHI-BRA, a wearable non-invasive smart bra combining thermography and bioimpedance, to distinguish women with and without breast lesions. A prospective feasibility design used a calibration cohort (n=15) and an analysis cohort (n=26), assessing diagnostic performance with ROC analysis using mammography as reference. Temperature-based modeling reached an AUC of 80.8% with balanced sensitivity and specificity; exploratory bioimpedance showed higher specificity with lower sensitivity. 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Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license.  \n1 Plateforme Transversale de Recherche Clinique de l’Institut de Cancérologie, Hospices Civils de Lyon,  \n69495 Pierre-Bénite, France  \n2 Research and Development Center, RunSys, 162 Lot le Verger, 69380 Chasselay, France  \n3 Service de Gynécologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, 69004 Lyon, France; [marion.cortet@chu-lyon.fr](marion.cortet@chu-lyon.fr) (M.C.)  \n4 Pôle de Santé Public, Hospices Civils de Lyon, 69 003 Lyon, France  \n5 Service d’Imageries Médicales, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, 69004 Lyon, France  \n* Correspondence: [anne-sophie.belmont@chu-lyon.fr](anne-sophie.belmont@chu-lyon.fr) (A.-S.B.); [marie-valerie.moreno@runsys.eu](marie-valerie.moreno@runsys.eu) (M.-V.M.)† These authors contributed equally to this work.  \nAbstract  \n(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.  \nKeywords: breast cancer screening; wearable medical device; thermography; bioimpedance; smart bra; first-in-human study  \n1. Introduction  \nBreast cancer remains a major public health concern, with its incidence continuing to rise worldwide. It is the second-most commonly diagnosed cancer globally, accounting  \nfor 2.3 million new cases in 2022, and is the fourth leading cause of cancer-related deaths across all sexes [1] .  \nCurrent screening methods rely primarily on mammography. However, mammography exposes patients to ionizing radiation, which accumulates with repeated screenings over time. Additionally, its sensitivity decreases in the presence of dense breast tissue, particularly in premenopausal women. As a result, mammography is not ideally suited for screening younger w","cbCaiq1Csjdv43zA","https://ap.wps.com/l/cbCaiq1Csjdv43zA","pdf",1389348,11,"English","# Abstract\n# Introduction","[{\"question\":\"What is PHI-BRA and what diagnostic signals does it use?\",\"answer\":\"PHI-BRA is a wearable, non-invasive smart bra that combines thermography and bioimpedance signals for breast monitoring and lesion discrimination.\"},{\"question\":\"How was diagnostic performance evaluated in this first-in-human study?\",\"answer\":\"A prospective feasibility study used a calibration cohort and an analysis cohort, with ROC analysis assessing performance using mammography as the reference standard.\"},{\"question\":\"What were the key findings for temperature-based and bioimpedance models?\",\"answer\":\"The temperature-based model achieved an AUC of 80.8%, with sensitivity and specificity at an optimal threshold. Exploratory bioimpedance analyses showed lower sensitivity but high specificity, limited by sensor contact stability.\"}]","Assessing the Diagnostic Performance of a Smart Bra Using Temperature and Bioimpedance for Breast Cancer Detection - A First-in-Human Study | PDF",1790081967,28]