Abstract

Although mammography has been the gold standard for the early detection of breast cancer, if a woman has dense breast tissue, a false negative diagnosis may occur. Breast ultrasound, whether hand-held or automated, is a useful adjunct to mammography but adds extra time and cost. The primary aim was to demonstrate that our second-generation Aceso system, which combines full-field digital mammography (FFDM) and automated breast ultrasound (ABUS) in a single platform, is able to produce improved quality images that provide clinically meaningful results. Aceso was first tested using two industry standards: a Contrast Detail Mammography (CDMAM) phantom to assess the FFDM images, and the CIRS 054GS phantom to evaluate the ABUS images. In addition, 25 women participated in a clinical trial: 14 were healthy volunteers, while 11 were patients referred by the breast clinic at Groote Schuur Hospital. The CDMAM phantom results showed the FFDM results were better than the European Reference (EUREF) standard of “acceptable” and were approaching “achievable”. The ABUS results showed a lateral and axial spatial resolution of 0.5 mm and an adequate depth penetration of 80 mm. Our second-generation Aceso system, with its improved quality of clinical FFDM and ABUS images, has demonstrated its potential for the early detection of breast cancer in a busy clinic.

Highlights

  • For the past 50 years, mammography—X-ray images of cranio-caudal (CC) and medio-lateral oblique (MLO) views of both breasts—has been the gold standard to diagnose healthy women for the early detection of breast cancer [1]

  • The sensitivity of full-field digital mammography (FFDM) varies from 75% to 90%, while the specificity ranges from 90% to 95% [4]

  • Detail Mammography (CDMAM) phantom was located between two plates andphantom placed on thenumber breast platform, providing

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Summary

Introduction

For the past 50 years, mammography—X-ray images of cranio-caudal (CC) and medio-lateral oblique (MLO) views of both breasts—has been the gold standard to diagnose healthy women for the early detection of breast cancer [1]. The sensitivity of full-field digital mammography (FFDM) varies from 75% to 90%, while the specificity ranges from 90% to 95% [4]. It has long been recognized that mammography performs poorly if a woman has dense breast tissue, which is often the case for pre-menopausal women younger than 50, and the sensitivity falls to less than 50% [5]. The dense fibro-glandular tissue masks the underlying tumours and a false negative diagnosis can have devastating consequences for the patient: a poorer prognosis and more expensive treatment [6].

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