Rationale and Objectives
To assess how well radiologists visualize relevant features of lesions seen with automated breast volumetric scanning (ABVS) in comparison to hand-held breast ultrasound in women going to breast biopsy.
Materials and Methods
Twenty-five subjects were recruited from women who were scheduled to undergo a breast biopsy for at least one Breast Imaging–Reporting and Data System four or five lesion identified in a diagnostic setting. In this institutional review board–approved study, the subjects underwent imaging of the breast(s) of concern using a dedicated system that allowed both hand-held breast ultrasound and ABVS. Five experienced breast radiologists reviewed the 30 lesions in 25 subjects in a reader study. Each reader was asked to specify the lesion type, size, imaging features, Breast Imaging–Reporting and Data System, and suspicion of malignancy and to compare the lesion characteristics of shape and margins between the two modalities.
Results
Seven (23.3%) masses were malignant and 23 (76.4%) were benign. Across all lesions regardless of size or final pathology, there was no significant difference in sensitivity or specificity ( P > .15) between the two modalities. For malignant lesions, the reader visualization confidence scores between the two ultrasound modalities were not significantly different ( P > .1). However, analysis for nonmalignant cases showed a statistically significant increase in reader visualization confidence in lesion shape and margins ( P < .001).
Conclusions
Radiologists showed increased confidence in visualization of benign masses and equal confidence in suspicious masses with ABVS imaging. This information could help decrease the need for additional hand-held imaging after automated whole breast ultrasound.
Breast cancer is the most commonly diagnosed noncutaneous cancer in American women . Mammography remains the gold standard for screening women for breast cancer, but the major limitation of this technology is decreased sensitivity in women with dense breast tissue . Even with improvements in breast cancer detection using digital mammography, the sensitivity of mammography in women with dense breasts tends to be lower than the reported sensitivity of mammography in women with nondense breasts because of the added challenge of detecting breast cancers that may be obscured by overlapping breast tissue . This concept is known as “masking” . Unfortunately, masking is common in women with dense breasts. Dense breast tissue is found in 40%–60% of all women, of any age, undergoing mammographic imaging . Thus, this is a major contributing factor for the use of an additional screening modality to be used in conjunction with mammography. Ultrasound is one such tool that is being studied as a potential supplemental screening modality .
Ultrasound is an alternative technology that is not limited by breast density and has served as an important adjunct to mammography in the diagnostic evaluation of breast lesions for several decades. Although a highly sensitive imaging modality in breast cancer detection and evaluation, current ultrasound breast scanning technology requires a hand-held transducer. Evaluation is limited by the small hand-held ultrasound transducer size and to areas of the breast that are scanned. Thus, assessment is often deficient because the whole breast may not be evaluated by the operator. In addition, other limitations of conventional ultrasound are primarily because of operator-dependence and poor standardization of technique, which can result in missed cancers and unnecessary biopsies, additional medical expenses, and patient anxiety .
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Materials and methods
Subjects
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HHBUS and ABVS
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Training and Start Up
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Image Acquisition
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Postimaging
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Reader Study
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Statistical Analysis
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Results
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Table 1
Breast Lesion Pathology and Size
Lesion Number Pathology Largest Size (cm) 1 Intraductal papilloma 2.0 2 Fat necrosis and pseudoangiomatous stromal hyperplasia 2.2 3 Fat necrosis with chronic inflammation 1.6 4 Fibrocystic changes 1.1 5 Focal adenosis 0.5 6 Pseudoangiomatous stromal hyperplasia 1.0 7 Fibrocystic changes 1.6 8 Intraductal papilloma 1.5 9 Invasive ductal carcinoma grade II; DCIS, nuclear grade 2, solid type 1.5 10 Invasive ductal carcinoma with tubular features, grade I 0.6 11 Fibroadenoma 0.6 12 Fibrocystic changes 0.6 13 Fibrocystic changes 0.4 14 Focal chronic inflammation 1.1 15 Fibrocystic changes 0.7 16 Fibrocystic changes 2.0 17 Fibrocystic changes 0.6 18 Invasive ductal carcinoma grade III; DCIS, nuclear grade 3, solid type 2.0 19 Fibrocystic changes 2.0 20 Fibroadenoma 3.4 21 Fibrocystic changes 1.8 22 Fibrocystic changes 0.9 23 Invasive ductal carcinoma, grade III 1.4 24 Invasive lobular carcinoma, grade II 1.0 25 Invasive ductal carcinoma, grade II 1.0 26 Fibroadenoma 2.0 27 Ductal carcinoma in situ, nuclear grade 2, cribriform type 0.8 28 Fat necrosis with dense fibrosis 2.5 29 Fibrocystic changes 1.0 30 Fibroadenoma 1.6
DCIS, ductal carcinoma in situ.
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Table 2
Sensitivity and Specificity of ABVS and HHBUS Based on Combined Readers’ BI-RADS and Clinical Suspicion of Malignancy Scale
Measures BI-RADS Scale Clinical Suspicion Scale ABVS HHBUS ABVS HHBUS Sensitivity 97.1% 97.1% 94.3% 91.4% Specificity 27.8% 30.4% 36.5% 39.1%P Value >.15 >.15
ABVS, automated breast volumetric scanning; BI-RADS, Breast Imaging–Reporting and Data System; HHBUS, hand-held breast ultrasound.
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Table 3
Mean Reader Confidence Scores of ABVS and HHBUS for the Two Reading Conditions for all Lesions. The Average Confidence Score Scale is −3 to 3
Diagnostic Result Condition I: ABVS vs. HHBUS Condition II: HHBUS vs. ABVS Lesion Shape/Morphology Lesion Margin ABVS Coronal View Only vs. HHBUS Lesion Shape/Morphology ABVS Coronal View Only vs. HHBUS Lesion Margin Lesion Shape/Morphology Lesion Margin HHBUS vs. Coronal View Only ABVS Lesion Shape/Morphology HHBUS vs. ABVS Coronal View Only Lesion Margin Cancer 0.46 0.43 0.63 0.49 0.31 0.34 0.43 0.37 Noncancer 0.70 0.70 1.31 1.23 0.37 0.33 0.70 0.76
ABVS, automated breast volumetric scanning; HHBUS, hand-held breast ultrasound.
Table 4
Mean Reader Confidence Scores of ABVS and HHBUS for the Two Reading Conditions for Lesions in Subjects with Dense Breasts. The Average Confidence Score Scale is −3 to 3
Diagnostic Result Condition I: ABVS vs. HHBUS Condition II: HHBUS vs. ABVS Lesion Shape/Morphology Lesion Margin ABVS Coronal View Only vs. HHBUS Lesion Shape/Morphology ABVS Coronal View Only vs. HHBUS Lesion Margin Lesion Shape/Morphology Lesion Margin HHBUS vs. Coronal View Only ABVS Lesion Shape/Morphology HHBUS vs. ABVS Coronal View Only Lesion Margin Cancer 0.30 0.30 0.35 0.35 0.1 0.05 0.30 0.20 Noncancer 0.58 0.69 1.00 1.00 0.29 0.27 0.51 0.55
ABVS, automated breast volumetric scanning; HHBUS, hand-held breast ultrasound.
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Discussion
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Conclusions
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Acknowledgments
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