Noninvasive and Low-Cost Technique for Early Detection of Clinically Relevant Breast Lesions Using a Handheld Point-of-Care Medical Device (iBreastExam): Prospective Three-Arm Triple-Blinded Comparative Study

Context With limited access to mechanisms of early detection, the vast majority of breast cancer cases present at late stages in developing countries. Objective To determine the clinical efficacy of a handheld point-of-care medical device that could potentially assist allied healthcare workers to perform standardized Clinical Breast Examination in low-resource settings. Design, Setting and Participants Nine hundred and eighty-nine healthy women visiting Manipal Hospital, Bangalore, for annual health check were recruited for bilateral breast examinations. Additionally, 20 women attending the hospital with breast-related symptoms were also recruited as part of the opportunistic screening program. Each woman was examined by three independent methods, each blinded to the other two: iBreastExam (iBE), Clinical Breast Examination (CBE) by an expert clinician and Breast Imaging (mammography or breast ultrasound). Main Outcome Measures Sensitivity, Specificity, PPV, NPV for iBE and CBE were derived with Breast Imaging tests used as reference standard. Results Out of 916 enrolled participants, 93 were confirmed by imaging to have at least one breast lesion. Clinical Breast Examination in comparison with imaging detected breast lesions with Sn = 65 %, Sp = 94 %, PPV = 52 %, NPV = 96 %, and iBreastExam reported Sn = 84 %, Sp = 94 %, PPV = 60 % and NPV = 98 %. In women below age 40 (314 participants), iBE detected breast lesions with Sn = 85 %, Sp = 93 %. All malignant lesions were identified by iBE, while one non-palpable malignant lesion was missed by clinician CBE. Conclusion The point-of-care Breast Imaging device (iBreastExam) performed with significantly better sensitivity, by 19 %, than CBE to detect breast lesions while reporting high specificity (94 %) and NPV (98 %). In younger women population under the age of 40 years, where the prevalence of dense breast is high, iBreastExam demonstrated high-performance characteristics. iBreastExam detected all malignant lesions in this study, while the clinician’s CBE missed to detect a non-palpable malignant lesion. iBreastExam can be a promising tool to provide clinically effective and standardized breast examinations in low-resource settings to detect breast lesions at early stages. The device can also be an effective screening tool for younger women with dense breasts.