Evaluating the features of breast lesions identified by bimodal breast examination: a real-world study.

Background: Several image-based diagnostic methods have been developed to examine the features of breast lesions among women, while the value of combining palpation imaging and ultrasound by a bimodal breast examination system is still unknown. Methods: A real-world study was conducted among 424 patients who visited Fujian Maternal and Child Health Hospital and Fujian Obstetrics and Gynecology Hospital, and used the Bimodal Breast Exam (BBE) systems which combines palpation imaging and ultrasound imaging. Among them, 97 patients had additional ultrasound, mammogram, or pathological examination. These patients were used to evaluate the consistency and efficacy of the BBE in interpreting the features of breast lesions as compared to results of ultrasound, mammogram, and pathological examinations. Results: The BBE system detected 1517 lesions with palpation imaging, 1126 lesions with ultrasound examination (950 solid lesions and 176 cysts), and 391 non mass lesions. Among them, 404 patients were diagnosed as benign and 20 were diagnosed as malignant tumor. However, 12, 9 and 4 cases were diagnosed as malignant tumors by ultrasound, mammogram and pathological examination, respectively. Compared with the integrative results of ultrasound, mammogram and pathology, the sensitivity of BBE is 55.6%, and the specificity is 90.9%, with a kappa coefficient of 0.387 (0.110, 0.665), indicating moderate consistency. Conclusions: In clinical practice, BBE can be used to evaluate features of breast lesions with a high specificity. The diagnostic efficacy is comparable to the integrative results of ultrasound, mammography, and pathological examination.