iBreast is an unique portable handheld non-invasive medical device which is developed in India to screen patients in rural and suburban areas. It employs a lead zirconate titanate piezoelectric cantilever sensor and can accurately detect abnormal areas by comparing the degree of deflection. Our tripled blinded study compares it with Clinical Breast Examination and Mammography and breast ultrasound.
1019 women visiting a tertiary Indian hospital, for annual health check were recruited. 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).
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.
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. iBreast- Exam 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.
Manipal Coprehensive Cancer Center.
Has not received any funding.
The author has declared no conflicts of interest.