Abstract
Purpose
The aim of this study was to test a novel dual-modality imaging system that combines
full-field digital mammography (FFDM) and automated breast ultrasound (ABUS) in a
single platform. Our Aceso system, named after the Greek goddess of healing, was specifically
designed for the early detection of cancer in women with dense breast tissue.
Materials and Methods
Aceso was first tested using two industry standards: a Contrast Detail Mammography
(CDMAM) phantom as endorsed by European Reference Organisation for Quality Assured
Breast Screening and Diagnostic Services was used to assess the FFDM images; and the
CIRS 040GSE ultrasound phantom was imaged to evaluate the quality of the ABUS images.
In addition, 58 women participated in a clinical trial: 51 were healthy volunteers
aged between 40 and 65, while 7 were patients referred by the breast clinic, 6 of
whom had biopsy-proven breast cancer.
Results
The CDMAM tests showed that the FFDM results were “acceptable” but fell short of “achievable”
which was attributed to the low dose used. The ABUS images had good depth penetration
(80 mm) and adequate axial resolution (0.5 mm), but the lateral resolution of 2 mm
was judged to be too coarse. In a 42-year-old volunteer with extremely dense breast
tissue, the ABUS modality detected a lesion (a benign cyst) that was mammographically
occult in the FFDM image. For a 73-year-old patient with fatty breasts, a malignant
lesion was successfully detected and co-registered in the FFDM and ABUS images. On
average, each woman spent less than 11 min in the acquisition room.
Conclusions
While there is room for improvement in the quality of both the FFDM and ABUS images,
Aceso has demonstrated its ability to acquire clinically meaningful images for a range
of women with varying breast densities and, therefore, has potential as a screening
device.
Keywords
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Article info
Publication history
Published online: December 03, 2015
Accepted:
November 23,
2015
Received in revised form:
November 2,
2015
Received:
June 12,
2015
Footnotes
☆Conflicts of interest: CLV and TSD are board members and shareholders in CapeRay. QSH has no conflict of interest. RVB, JAB, JH, SO, and HSW are employees and shareholders in CapeRay. BCG, MWM, RVS, and NCV are engineering contractors to CapeRay.
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© 2015 Elsevier Inc. All rights reserved.
