Diagnostic accuracy of tactile imaging in selecting patients with palpable breast abnormalities: a prospective comparative study.

Abstract

Unnecessary referrals of patients with breast lumps represent a significant issue, since only a few patients actually have lumps when examined by a breast specialist. Tactile imaging (TI) is a novel modality in breast diagnostics armamentarium. The aim of this study was to assess TI's diagnostic performance and compare it to clinical breast examination (CBE). This is a prospective, blinded, comparative study of 276 consecutive patients. All patients underwent conventional imaging and tissue sampling if either a radiological or a palpable abnormality was present. Sensitivity, specificity and positive and negative predictive values for CBE and TI were calculated. Radiological findings and final diagnosis based on histology and/or cytology were used as reference standards. Receiver operator characteristic (ROC) curve analysis was also performed for each method. Sensitivity and specificity of TI in detecting radiologically proven abnormalities were 85.5 % and 35 %, respectively. CBE's sensitivity was 80.3 % and specificity 76 %. In detecting a histopathological entity according to histology/cytology, sensitivity was 88.2 % for TI and 81.6 % for CBE. Specificity was 38.5 % and 85.7 % for TI and CBE, respectively. These results suggest a trend towards higher sensitivity of TI compared to CBE but significantly lower specificity. Subgroup analysis revealed superior sensitivity of TI in detecting a histological entity in pre-menopausal women. However, CBE's overall performance was superior compared to TI's according to ROC curve analysis. Although further research is necessary, the use of TI by the primary care physician as a selection tool for referring patients to a breast specialist should be considered especially in pre-menopausal women.