Can the Clinical Utility of iBreastExam, a Novel Device, Aid in Optimizing Breast Cancer Diagnosis? A Systematic Review.

PURPOSE: A portable, cost-effective, easy-to-use, hand-held Intelligent Breast Exam (iBE), which is a wireless, radiation-free device, may be a valuable screening tool in resource-limited settings. While multiple studies evaluating the use of iBE have been conducted worldwide, there are no cumulative studies evaluating the iBE's performance. Therefore this review aims to determine the clinical utility and applicability of iBE compared with clinical breast examinations, ultrasound, and mammography and discuss its strengths and weaknesses when performing breast-cancer screening. METHODS: A systematic review was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Four electronic databases were searched: PubMed, Cochrane Library, Web of Science, and Google Scholar. RESULTS: The review included 11 studies with a total sample size of 16,052 breasts. The mean age ranged from 42 to 58 years. The sensitivity and specificity of the iBE ranged from 34.3% to 86% and 59% to 94%, respectively. For malignant lesions, iBE demonstrated a moderate to higher diagnostic capacity ranging from 57% to 93% and could identify tumor sizes spanning from 0.5 cm to 9 cm. CONCLUSION: Our findings underscore the potential clinical utility and applicability of iBE as a prescreening and triaging tool, which may aid in reducing the burden of patients undergoing diagnostic imaging in lower- and middle-income countries. Furthermore, iBE has shown to diagnose cancers as small as 0.5 cm, which can be a boon in early detection and reduce mortality rates. However, the encouraging results of this systematic review should be interpreted with caution because of the device's low sensitivity and high false-positive rates.