The results of this study show that cone-beam breast CT can be used to image the entire breast from chest wall to nipple with sufficient spatial and contrast resolution for detection of masses and calcifications at a radiation dose within the range of that of conventional mammography.

Purpose: To determine the mean and range of volumetric glandular fraction (VGF) of the breast in a diagnostic population using a high-resolution flat-panel cone-beam dedicated breast CT system. This information is important for Monte Carlo-based estimation of normalized glandular dose coefficients and for investigating the dependence of VGF on breast dimensions, race, and pathology. Methods: Image data from a clinical trial investigating the role of dedicated breast CT that enrolled 150 women were retrospectively analyzed to determine the VGF. The study was conducted in adherence to a protocol approved by the institutional human subjects review boards and written informed consent was obtained from all study participants. All participants in the study were assigned BI-RADS R 4 or 5 as per the American College of Radiology assessment categories after standard diagnostic work-up and underwent dedicated breast CT exam prior to biopsy. A Gaussian-kernel based fuzzy c-means algorithm was used to partition the breast CT images into adipose and fibroglandular tissue after segmenting the skin. Upon determination of the accuracy of the algorithm with a phantom, it was applied to 137 breast CT volumes from 136 women. VGF was determined for each breast and the mean and range were determined. Pathology results with classification as benign, malignant, and hyperplasia were available for 132 women, and were used to investigate if the distributions of VGF varied with pathology. Results: The algorithm was accurate to within ±1.9% in determining the volume of an irregular shaped phantom. The study mean (± inter-breast SD) for the VGF was 0.172 ± 0.142 (range: 0.012-0.719). VGF was found to be negatively correlated with age, breast dimensions (chest-wall to nipple length, pectoralis to nipple length, and effective diameter at chest-wall), and total breast volume, and positively correlated with fibroglandular volume. Based on pathology, pairwise statistical analysis (Mann-Whitney test) indicated that at the 0.05 significance level, there was no significant difference in distributions of VGF without adjustment for age between malignant and nonmalignant breasts (p = 0.41). Pairwise comparisons of the distributions of VGF in increasing order of mammographic breast density indicated all comparisons were statistically significant (p < 0.002). Conclusions: This study used a different clinical prototype breast CT system than that in previous studies to image subjects from a different geographical region, and used a different algorithm for analysis of image data. The mean VGF estimated from this study is within the range reported in previous studies, indicating that the choice of 50% glandular weight fraction to represent an average breast for Monte Carlo-based estimation of normalized glandular dose coefficients in mammography needs revising. In the study, the distributions of VGF did not differ significantly with pathology.

This study retrospectively analyzed the mean glandular dose (MGD) to 133 breasts from 132 subjects, all women, who participated in a clinical trial evaluating dedicated breast CT in a diagnostic population. The clinical trial was conducted in adherence to a protocol approved by institutional review boards and the study participants provided written informed consent. Individual estimates of mean glandular dose to each breast from dedicated breast CT was obtained by combining x-ray beam characteristics with estimates of breast dimensions and fibroglandular fraction from volumetric breast CT images, and using normalized glandular dose coefficients. For each study participant and for the breast corresponding to that imaged with breast CT, an estimate of the MGD from diagnostic mammography (including supplemental views) was obtained from the DICOM image headers for comparison. This estimate uses normalized glandular dose coefficients corresponding to a breast with 50% fibroglandular weight fraction. The median fibroglandular weight fraction for the study cohort determined from volumetric breast CT images was 15%. Hence, the MGD from diagnostic mammography was corrected to be representative of the study cohort. Individualized estimates of MGD from breast CT ranged from 5.7 mGy to 27.8 mGy. Corresponding to the breasts imaged with breast CT, the MGD from diagnostic mammography ranged from 2.6 to 31.6 mGy. The mean (± inter-breast SD) and the median MGD (mGy) from dedicated breast CT exam were 13.9±4.6 and 12.6, respectively. For the corresponding breasts, the mean (± inter-breast SD) and the median MGD (mGy) from diagnostic mammography were 12.4±6.3 and 11.1, respectively. Statistical analysis indicated that at the 0.05 level, the distributions of MGD from dedicated breast CT and diagnostic mammography were significantly different (Wilcoxon signed ranks test, p = 0.007). While the interquartile range and the range (maximum-minimum) of MGD from dedicated breast CT was lower than diagnostic mammography, the median MGD from dedicated breast CT was approximately 13.5% higher than that from diagnostic mammography. The MGD for breast CT is based on a 1.45 mm skin layer and that for diagnostic mammography is based on a 4 mm skin layer; thus, favoring a lower estimate for MGD from diagnostic mammography. The median MGD from dedicated breast CT corresponds to the median MGD from 4 to 5 diagnostic mammography views. In comparison, for the same 133 breasts, the mean and the median number of views per breast during diagnostic mammography were 4.53 and 4, respectively. Paired analysis showed that there was approximately equal likelihood of receiving lower MGD from either breast CT or diagnostic mammography. Future work will investigate methods to reduce and optimize radiation dose from dedicated breast CT.

Mammography is the gold standard in routine screening for the detection of breast cancer in the general population. However limitations in sensitivity, particularly in dense breasts, has motivated the development of alternative imaging techniques such as digital breast tomosynthesis, whole breast ultrasound, breast specific gamma imaging, and more recently dedicated breast computed tomography or “breast CT”. Virtually all diagnostic work-ups of asymptomatic nonpalpable findings arise from screening mammography. In most cases, diagnostic mammography and ultrasound are sufficient for diagnosis, with magnetic resonance imaging (MRI) playing an occasional role. Digital breast tomosynthesis, a limited-angle tomographic technique, is increasingly being used for screening. Dedicated breast CT has full three-dimensional (3D) capability with near-isotropic resolution, which could potentially improve diagnostic accuracy. In current dedicated breast CT clinical prototypes, 300-500 low-dose projections are acquired in a circular trajectory around the breast using a flat panel detector, followed by image reconstruction to provide the 3D breast volume. The average glandular dose to the breast from breast CT can range from as little as a two-view screening mammogram to approximately that of a diagnostic mammography examination. Breast CT displays 3D images of the internal structures of the breast; therefore, evaluation of suspicious features like microcalcifications, masses, and asymmetries can be made in multiple anatomical planes from a single scan. The potential role of breast CT for diagnostic imaging is illustrated here through clinical examples such as imaging soft tissue abnormalities and microcalcifications. The potential for breast CT to serve as an imaging tool for extent of disease evaluation and for monitoring neoadjuvant chemotherapy response is also illustrated.

Purpose: To determine the mean and range of location-averaged breast skin thickness using highresolution dedicated breast CT for use in Monte Carlo-based estimation of normalized glandular dose coefficients. Methods: This study retrospectively analyzed image data from a clinical study investigating dedicated breast CT. An algorithm similar to that described by Huang et al. ["The effect of skin thickness determined using breast CT on mammographic dosimetry," Med. Phys. 35(4), 1199-1206 (2008)] was used to determine the skin thickness in 137 dedicated breast CT volumes from 136 women. The location-averaged mean breast skin thickness for each breast was estimated and the study population mean and range were determined. Pathology results were available for 132 women, and were used to investigate if the distribution of location-averaged mean breast skin thickness varied with pathology. The effect of surface fitting to account for breast curvature was also studied. Results: The study mean (± interbreast SD) for breast skin thickness was 1.44 ± 0.25 mm (range: 0.87-2.34 mm), which was in excellent agreement with Huang et al. Based on pathology, pair-wise statistical analysis (Mann-Whitney test) indicated that at the 0.05 significance level, there were no significant difference in the location-averaged mean breast skin thickness distributions between the groups: benign vs malignant (p = 0.223), benign vs hyperplasia (p = 0.651), hyperplasia vs malignant (p = 0.229), and malignant vs nonmalignant (p = 0.172). Conclusions: Considering this study used a different clinical prototype system, and the study participants were from a different geographical location, the observed agreement between the two studies suggests that the choice of 1.45 mm thick skin layer comprising the epidermis and the dermis for breast dosimetry is appropriate. While some benign and malignant conditions could cause skin thickening, in this study cohort the location-averaged mean breast skin thickness distributions did not differ significantly with pathology. The study also underscored the importance of considering breast curvature in estimating breast skin thickness.

Objective:This pilot study was undertaken to compare radiation dose, relative visibility/conspicuity of biopsy-proven lesions, and relative patient comfort in diagnostic mammography and dedicated cone-beam breast computed tomography (CBBCT) in Breast Imaging-Reporting and Data System (BI-RADS)® 4 or 5 lesions.Materials and Methods:Thirty-six consecutive patients (37 breasts) with abnormal mammographic and/or ultrasound categorized as BI-RADS® 4 or 5 lesions were evaluated with CBBCT prior to biopsy. Administered radiation dose was calculated for each modality. Mammograms and CBBCT images were compared side-by-side and lesion visibility/conspicuity was qualitatively scored. Histopathology of lesions was reviewed. Patients were administered a survey for qualitative evaluation of comfort between the two modalities.Results:CBBCT dose was similar to or less than diagnostic mammography, with a mean dose of 9.4 mGy (±3.1 SD) for CBBCT vs. 16.9 mGy (±6.9 SD) for diagnostic mammography in a total of 37 imaged breasts (P<0.001). Thirty-three of 34 mammographic lesions were scored as equally or better visualized in CBBCT relative to diagnostic mammography. Characterization of high-risk lesions was excellent. Patients reported greater comfort in CBBCT imaging relative to mammography.Conclusion:Our experience of side-by-side comparison of CBBCT and diagnostic mammography in BI-RADS® 4 and 5 breast lesions demonstrated a high degree of correlation between the two modalities across a variety of lesion types. Owing to favorable radiation dose profile, excellent visualization of lesions, and qualitative benefits including improved patient comfort, excellent field-of-view, and more anatomical evaluation of lesion margins, CBBCT offers a promising modality for diagnostic evaluation of breast lesions.

Dedicated breast computed tomography (CT) is the latest in a long history of breast imaging techniques dating back to the 1960s. Breast imaging is performed both for cancer screening as well as for diagnostic evaluation of symptomatic patients. Dedicated breast CT received US Food and Drug Administration approval for diagnostic use in 2015 and is slowly gaining recognition for its value in diagnostic 3-dimensional imaging of the breast, and also for injected contrast-enhanced imaging applications. Conventional mammography has known limitations in sensitivity and specificity, especially in dense breasts. Breast tomosynthesis was US Food and Drug Administration approved in 2011 and is now widely used. Dedicated breast CT is the next technological advance, combining real 3-dimensional imaging with the ease of contrast administration. The lack of painful compression and manipulation of the breasts also makes dedicated breast CT much more acceptable for the patients.

Objectives We study the performance of an artificial intelligence (AI) program designed to assist radiologists in the diagnosis of breast cancer, relative to measures obtained from conventional readings by radiologists. Methods A total of 10 radiologists read a curated, anonymized group of 299 breast ultrasound images that contained at least one suspicious lesion and for which a final diagnosis was independently determined. Separately, the AI program was initialized by a lead radiologist and the computed results compared against those of the radiologists. Results The AI program's diagnoses of breast lesions had concordance with the 10 radiologists' readings across a number of BI‐RADS descriptors. The sensitivity, specificity, and accuracy of the AI program's diagnosis of benign versus malignant was above 0.8, in agreement with the highest performing radiologists and commensurate with recent studies. Conclusion The trained AI program can contribute to accuracy of breast cancer diagnoses with ultrasound.