Ultrasound breast cancer screening in dense parenchyma: The value of computer aided detection system for mammography (single-center, prospective, randomized clinical trial)

Abstract

Purpose. To compare the results of screening ultrasound (US) in women with dense (ACR C-D) breast parenchyma, with no suspicious changes at mammography, with and without considering the CAD results during the examination. Materials and methods. We randomized 2078 women aged 40-72 years old for breast US (US group) or CAD + breast US with targeted analysis of the areas marked by CAD on the mammograms (CAD + US group). Results. In the US group we found 16 breast carcinomas (BC) (median: 15 mm, range: 8-24 mm), in the CAD + US group - 22 BCs (median: 10 mm, range: 5-24 mm). 3 of the 16 BCs (18.75%) in the US group and 11 of 22 (50.00%) BCs in the CAD + US group (p<0.05) were less than 1 cm. BCs were revealed only during the targeted scanning of the CAD marking area in 5 of 11 women, and all these BCs were ≤1 CM. The rate of benign le-sions required biopsy was 76 of 1039 (7.31%) - in the US group and 68 of 1039 (6.54%) - in the CAD + US group (p>0.05). During the 3-year follow up we found 9 more BCs in the US group and 2 more BCs in the CAD + US group (p<0,05). Discussion. The probability of ACR C-D parenchyma in another sample of 10000 mammography sets was: 51.61% - in women of 40-44 years old, 37.10% - in women of 45-49 years old, 13.22% - in women of 50-54 years old, 12.07% - in women of 55-59 years old, 8.41% - ≥60 years old. Conclusion. In the mammographically dense breast parenchyma the targeted ultra-sound of the areas marked by CAD as suspicious significantly increased the small BCs de-tectability and significantly decreased the rate of BCs revealed during the 3-year follow up with no raise of unnecessary biopsy rate.