Artificial intelligence breast ultrasound and handheld ultrasound in the BI-RADS categorization of breast lesions: A pilot head to head comparison study in screening program.

Background: Artificial intelligence breast ultrasound diagnostic system (AIBUS) has been introduced as an alternative approach for handheld ultrasound (HHUS), while their results in BI-RADS categorization has not been compared.

Methods: This pilot study was based on a screening program conducted from May 2020 to October 2020 in southeast China. All the participants who received both HHUS and AIBUS were included in the study ( = 344). The ultrasound videos after AIBUS scanning were independently watched by a senior radiologist and a junior radiologist. Agreement rate and weighted Kappa value were used to compare their results in BI-RADS categorization with HHUS.

Results: The detection rate of breast nodules by HHUS was 14.83%, while the detection rates were 34.01% for AIBUS videos watched by a senior radiologist and 35.76% when watched by a junior radiologist. After AIBUS scanning, the weighted Kappa value for BI-RADS categorization between videos watched by senior radiologists and HHUS was 0.497 ( < 0.001) with an agreement rate of 78.8%, indicating its potential use in breast cancer screening. However, the Kappa value of AIBUS videos watched by junior radiologist was 0.39, when comparing to HHUS.

Conclusion: AIBUS breast scan can obtain relatively clear images and detect more breast nodules. The results of AIBUS scanning watched by senior radiologists are moderately consistent with HHUS and might be used in screening practice, especially in primary health care with limited numbers of radiologists.