Diagnostic accuracy of iBreastExam and clinical breast examination using mammography and ultrasonography as standards: a single-centre study in North India.

Abstract

Background: Breast cancer remains the leading cause of cancer-related mortality among women. The high mortality rate is due to late detection, low awareness, inadequate screening programs, and limited access to diagnostic and treatment options.

Objectives: Aim is to evaluate the diagnostic performance of iBreastExam (iBE) compared with Clinical Breast Examination (CBE) with mammography/USG as the reference standard for for detection of breast lesions requiring further diagnostic workup (BI-RADS 4-5). The secondary objective was to assess the utility of iBE in suspicious breast lesion screening.

Methods: A diagnostic accuracy study conducted at a tertiary care centre, included women (18-60 years) visiting in breast cancer OPD. CBE, iBE (index test), and Mammography with Ultrasound Breast (reference standard) were performed by trained technicians blinded to either of the test results. Diagnostic accuracy was analyzed per patient. Technicians were also interviewed regarding the feasibility of iBE device usage.

Results: The study included 106 participants (mean age: 43.6 years). Per-patient analysis showed CBE sensitivity at 62.96% (42.27%-80.6%) and iBE at 70.37% (49.82%-86.25%). Specificity was 60.81% (48.77%-71.96%) for CBE and 74.67% (63.3%-84.01%) for iBE. After adjusting for clustering per breast, iBE sensitivity remained unchanged, but specificity decreased to 16%. Parallel testing increased sensitivity to 88.9% (71%-97.3%). Technicians found iBE to be time-efficient, acceptable, and comfortable for patients.

Conclusions: The iBE device may serve as a triage tool, however pending validation with histopathological endpoints.. It is time-efficient and comfortable for patients from the user's perspective.