Can the Smart detect^TM in breast ultrasound provide a second opinion?

Ultrasound and mammography alone may not always identify malignant breast lesions. Samsung Medison has added the Smart detect^TM (S-detect^TM) program to its ultrasound features, and this may improve the identification of benign and malignant breast lesions. Objective: To evaluate the accuracy of S-detect^TM, a new ultrasound added feature, and to identify benign and malignant breast lesions in women with symptoms or signs of focal breast disease. Methods: In a pilot study, the registered data of a selected 45 women is retrospectively audited and analyzed. These women, presenting with clinical symptoms of breast disease (diagnostic), were examined by mammography and ultrasound. The interpretation and Hand Held Ultrasound (HHUS) have been done with 2 radiologists determining the BIRADS classification results for every woman (benign or malignant). In addition, S-detect^TM was applied during the ultrasound examination, and S-detect^TM findings (benign or malignant) were recorded in either concordance or discordance with radiologists' findings. Biopsy was performed as a gold standard. Results: Among the enrolled 45 women in the study, 33 (73.3%) had concordant results with the radiologists while the remaining 12 (26.6%) were discordant, in 10 (22.2%) of the 12 discordant cases, S-detect^TM findings of benign contradicted radiologists' findings and in 2 of the cases, S-detect^TM findings of malignant contradicted radiologists' findings. In the 10 discordant cases where S-detect^TM recommended benign, only 2 were correct, but in the 2 discordant cases where S-detect^TM recommended malignant, both were correct. The overall accuracy of S-detect^TM was 82.22%, sensitivity 61.90%, but a specificity was 100%. Conclusion: The use of S-detect^TM in this study identified additional cases of malignancy, so this technology may be a useful tool in addition to mammography and US for the diagnosis of breast disease. The specificity of the S-detect^TM in this study is remarkably high; yet, the sensitivity is low. Despite a small number of cases, we suggest a larger scale study, to validate the clinical utility in using the B-mode plus S-detect^TM to enhance diagnosis in patients presenting with symptoms and signs of breast diseases