Ultra-Low Frequency Transmitted Ultrasound Breast Imaging vs DBT (Digital Breast Tomosynthesis): A Patient-Reported Outcome Study.

Purpose: Breast cancer screening remains a challenge in the United States. Many women do not get a mammogram because of pain associated with the exam, radiation exposure, false-positive results, and additional costs. Others who may benefit from annual screening do not qualify because of young age and radiation risk. We hypothesize that a novel volumetric transmitted breast ultrasound, Quantitative Transmission (QT) Scan may encourage more women to have annual breast cancer screening. Assessing results from patient-reported outcomes (PROs) may predict the value of newer, more desirable screening technologies. Participants and Methods: Pre- and post-menopausal women who qualified for breast cancer screening were enrolled in a prospective trial of Quantitative Transmission (QT Scan) vs traditional mammography via Digital Breast Tomosynthesis (DBT) Clinical Trials.gov NCT03052166. These women completed questionnaires to assess their experiences with QT Scan and DBT. Associations between QT Scan or DBT and differences in PRO scores were examined. Results: A total of 430 subjects completed the PRO instrument analyzed. A total of 36 questions were asked, 34 were paired for both QT and DBT and two were asked regarding exclusively the QT Scan. Physical discomfort, perceptions of safety and low efficacy, false-positive results and additional out-of-pocket expenses were concerns identified as highest risk for opting out of screening mammography (differences between 2.1 and 2.9 indicate significant differences between means and standard deviations using the Cohen's d statistic). Student's T-test shows a significance level of <10 -10. Statistically significant differences in PROs between QT Scan and DBT were observed by 14 of the 17 paired experience questions (p<0.001). Conclusion: Significant differences in PROs were found between QT scan and DBT, indicating women have significantly more negative experiences with traditional mammography via DBT and are less inclined to undergo screening mammography. Identification of PRO differences could be used to help identify a more desirable breast cancer screening modality.

A Multireader Multicase (MRMC) Receiver Operating Characteristic (ROC) Study Evaluating Noninferiority of Quantitative Transmission (QT) Ultrasound to Digital Breast Tomosynthesis (DBT) on Detection and Recall of Breast Lesions.

RATIONALE AND OBJECTIVES: Quantitative transmission (QT) imaging is an emerging volumetric ultrasound modality for women too young for mammography. QT images tissue without overlap seen in mammography, thereby can potentially improve breast mass detection and characterization and noncancer recall. We compared radiologists' interpretation of QT vs digital breast tomosynthesis (DBT) with a multireader multicase observer performance study. MATERIALS AND METHODS: Study subjects received screening DBT and QT scans in HIPAA-compliant, institutional review board-approved prospective case-collection studies at four clinical sites. Twenty-four Mammography Quality Standards Act-qualified radiologists interpreted 177 cases (66 with cancer, atypia, or solid mass and 111 normal or with nonsolid benign abnormality), first QT, then 2 weeks later DBT synthesized 2D-views. Readers reported up to three findings per case and for each finding a recall or no recall decision and confidence of that decision. The study hypothesis was area under receiver operating characteristic curve (AUC) of QT was noninferior to DBT. Sensitivity and specificity were also compared. RESULTS: AUC of QT (0.746 ± 0.028, mean ± SD) was noninferior to DBT (0.700 ± 0.028) for AUC difference margin of -0.05 (P < .05). AUC difference was 0.046 ± 0.028 (95% CI: [-0.008, 0.101]). Sensitivity was 70.6 ± 7.2% for QT and 85.2 ± 6.4% for DBT, specificity was 60.1 ± 12.3% vs 37.2 ± 11.0%, and both differences were statistically significant. Of a total of 21 cases of cysts, readers recommended recall, on average, in 1.1 ± 1.4 cases with QT, but not with DBT, and 10.6 ± 2.2 cases with DBT, but not with QT. CONCLUSION: QT can be a potential alternative to mammography for breast cancer screening of women too young to undergo mammography.

An Exploratory Multi-reader, Multi-case Study Comparing Transmission Ultrasound to Mammography on Recall Rates and Detection Rates for Breast Cancer Lesions.

BACKGROUND: Three-dimensional Quantitative Transmission (QT) ultrasound imaging is an emerging modality for improving the detection and diagnosis of breast cancer. QT ultrasound has high resolution and high contrast to noise ratio, making it effective in evaluating breast tissue. This study compares radiologists' performance of noncancer recall rates and lesion detection rates using QT Ultrasound versus full-field digital mammography (FFDM) in a cross section of female subjects. MATERIALS AND METHODS: In this multi-reader multi-case (MRMC) study, we examined retrospective data from two clinical trials conducted at five sites. All subjects received FFDM and QT scans within 90 days. Data were analyzed in a reader study with full factorial design involving 22 radiologists and 108 breast cases (42 normal, 39 pathology-confirmed benign, and 27 pathology-confirmed cancer cases). The main results used a random-reader random-case analysis adjusted for location bias performed after a primary predefined random-reader fixed-case analysis. RESULTS: The readers' mean rate of detecting lesions of any type was 4% higher (p-value > 0.05) with QT imaging. The mean non-cancer recall rate improved significantly, showing a decrease of 16% with QT (p-value = 0.03), at the expense of a 2% decrease in the mean cancer recall rate (p-value >0.05) in comparison to FFDM. Combining performance on cancer and noncancer recall rates, the mean area under the receiver operator curve of confidence scores improved significantly by 10% with QT (p-value = 0.01). CONCLUSION: This MRMC study indicates that QT improves non-cancer recall rates without substantially affecting cancer recall rates. The main limitation is the small number of cases from retrospective data. A larger prospective MRMC study is warranted for further assessment.

Accuracy of Cyst Versus Solid Diagnosis in the Breast Using Quantitative Transmission (QT) Ultrasound.

RATIONAL AND OBJECTIVES: This study aims to evaluate the diagnostic utility of breast imaging using transmission ultrasound. We present readers' accuracy in determining whether a breast lesion is a cyst versus a solid using transmission ultrasound as an adjunct to mammography. MATERIALS AND METHODS: This retrospective multi-reader, multi-case receiver operating characteristic study included 37 lesions seen on mammography and transmission ultrasound. Cyst cases were confirmed as cysts using their appearance on handheld ultrasound. Solid cases were confirmed as solids with pathology results. Fourteen readers performed blinded, randomized reads with mammography + quantitative transmission scan images, assigning both a confidence score (0-100) and a binary classification of cyst or solid. A 95% percentile bootstrap confidence interval (CI) was computed for the readers' mean receiver operating characteristic area, sensitivity, and specificity. RESULTS: Using the readers' binary classification of cyst or solid lesions, the mean sensitivity and specificity were 0.933 [95% CI: 0.837, 0.995] and 0.858 [95% CI: 0.701, 0.985], respectively. When the readers' confidence scores were used to distinguish a cyst versus solid, the mean receiver operating characteristic area was 0.920 [95% CI: 0.827, 0.985]. CONCLUSIONS: Transmission ultrasound can provide an accurate assessment of a cyst versus a solid lesion in the breast. Prospective clinical trials will further delineate the role of transmission ultrasound as an adjunct to mammography to increase specificity in breast evaluation.

Anatomy-Correlated Breast Imaging and Visual Grading Analysis Using Quantitative Transmission Ultrasound™.

Objectives. This study presents correlations between cross-sectional anatomy of human female breasts and Quantitative Transmission (QT) Ultrasound, does discriminate classifier analysis to validate the speed of sound correlations, and does a visual grading analysis comparing QT Ultrasound with mammography. Materials and Methods. Human cadaver breasts were imaged using QT Ultrasound, sectioned, and photographed. Biopsies confirmed microanatomy and areas were correlated with QT Ultrasound images. Measurements were taken in live subjects from QT Ultrasound images and values of speed of sound for each identified anatomical structure were plotted. Finally, a visual grading analysis was performed on images to determine whether radiologists' confidence in identifying breast structures with mammography (XRM) is comparable to QT Ultrasound. Results. QT Ultrasound identified all major anatomical features of the breast, and speed of sound calculations showed specific values for different breast tissues. Using linear discriminant analysis overall accuracy is 91.4%. Using visual grading analysis readers scored the image quality on QT Ultrasound as better than on XRM in 69%-90% of breasts for specific tissues. Conclusions. QT Ultrasound provides accurate anatomic information and high tissue specificity using speed of sound information. Quantitative Transmission Ultrasound can distinguish different types of breast tissue with high resolution and accuracy.

Mucocele-like lesions in the breast diagnosed with percutaneous biopsy: is surgical excision necessary?

OBJECTIVE: The purpose of this study was to determine the frequencies of atypia and cancer at excisional biopsy of lesions with a diagnosis of mucocele-like lesion (MLL) at percutaneous breast biopsy. MATERIALS AND METHODS: Retrospective review of 9286 lesions subjected to percutaneous imaging-guided biopsy identified MLLs in 35 (0.38%) patients. Medical records, imaging studies, and histologic results were reviewed. RESULTS: Of the 35 patients with core biopsy findings of MLL, 27 underwent stereotactic core needle biopsy (19 with microcalcifications, five with calcifications with an associated mass, and three with only a mass), and eight underwent ultrasound-guided core needle biopsy (four with a solid mass, three with a complex cystic mass). At core biopsy, 12 of 35 (34%) MLLs were associated with atypia (10 cases of atypical ductal hyperplasia, two of flat epithelial atypia), and 23 of 35 (66%) were benign MLL only. All 12 MLLs associated with atypia and 12 of 23 benign MLLs were surgically excised. Eleven patients did not undergo surgery, five of whom were lost to follow-up. One of the 12 (3% of the 35) MLLs associated with atypia was upgraded to DCIS. None were upgraded to invasive cancer. None of the benign MLLs were upgraded to malignancy, and findings at excision of four of the 23 (17%) benign MLLs led to a change in diagnosis to a high-risk lesion (three atypical ductal hyperplasia, one atypical lobular hyperplasia). CONCLUSION: MLL is a rare diagnosis but is encountered in large-volume breast practices. The findings are nonspecific with a range of imaging appearances. No imaging test is reliable for differentiating MLL from other suspicious lesions or lesions with associated atypia. Surgery is clearly warranted for MLL associated with atypia at core needle biopsy because it may be upgraded to malignancy upon excision. However, if the presence of atypia at excision of benign MLL will change clinical management, then benign MLL at core needle biopsy warrants surgical excision in some cases. In patients whose treatment will not change if atypia is found at excision, close surveillance with short-interval follow-up is a reasonable alternative.

Imaging approaches to diagnosis and management of common ductal abnormalities.

Ductal disease is an important, often overlooked, and poorly understood issue in breast imaging that results in delays in diagnosis and patient care. The differential diagnosis for an intraductal mass is broad and includes inspissated secretions, infection, hemorrhage, solitary or multiple papillomas, and malignancy. Each breast is composed of eight or more ductal systems, with most disease arising in the terminal ductal-lobular unit. Imaging evaluation of the ductal system usually entails a combination of mammography, galactography, ultrasonography (US), and in some cases magnetic resonance (MR) imaging. The most common finding with all modalities is ductal dilatation with a focal or diffuse abnormality. Benign diseases of the ducts include duct ectasia, blocked ducts, inflammatory infiltrates, periductal mastitis, apocrine metaplasia, intraductal papillomas, and papillomatosis. Malignant diseases of the ducts include ductal carcinoma in situ, invasive ductal carcinoma, and Paget disease. Most commonly performed with US or MR imaging guidance, percutaneous biopsy methods are helpful in diagnosis and management of ductal findings. Because most findings are smaller than 1 cm, located within a duct, and thus sometimes not visible after a single pass, vacuum-assisted devices help improve the accuracy of sampling.

Spectrum of disease in the male breast.

OBJECTIVE: The purpose of this article is to review the anatomy of the male breast and to describe the imaging findings of a variety of diseases that affect the male breast to better understand and recognize the imaging findings and underlying pathophysiology of diseases and conditions affecting this emerging subset of patients. CONCLUSION: Understanding the anatomy of the male breast is central to developing a differential diagnosis and delivering optimal care in male patients presenting with breast complaints. Diseases in the male breast can affect the skin and subcutaneous tissues, stroma and glandular elements, and neurovascular and lymphatic structures. Although the most commonly encountered disease entity is gynecomastia, men can develop many other benign and neoplastic diseases, including primary breast cancer. By incorporating clinical presentation with imaging findings on mammography and ultrasound, the breast imager can more effectively establish the correct diagnosis in males.

Avoiding pitfalls in mammographic interpretation.

There is a public misconception that screening mammography detects all breast malignancies. The objective of this pictorial essay is to review classic mammographic features of malignancy that, if missed, could potentially result in malpractice litigation. By identifying radiologic themes, we attempt to improve awareness about the imaging characteristics of a variety of subtle malignancies.

Sonographic hematoma-guided vs wire-localized lumpectomy for breast cancer: a comparison of margins and volume of resection.

HYPOTHESIS: Sonographic hematoma-guided (SHG) lumpectomy achieves better margin clearance with a smaller volume of resection compared with wire-localized (WL) lumpectomy. DESIGN: Retrospective study. SETTING: University Comprehensive Breast Center. PATIENTS: Consecutive patients treated over 6 months at the breast center with stereotactic biopsy-proven cancers that were not visualized on ultrasonography. The SHG and WL techniques were compared. MAIN OUTCOME MEASURES: The matching variables were age, mammographic abnormality, tumor size and type, and lymph node status. The outcome variables were the closest margin of resection, volume of resection, resection index (resection volume divided by tumor volume), and rate of margin revision. RESULTS: Twenty-nine patients had SHG lumpectomy and 34 had WL lumpectomy. The SHG and WL groups were similar in age, mammographic abnormality, tumor size and type, and lymph node status. The median (interquartile range) closest margin was 5.0 (5-8) mm in the SHG group vs 3.5 (1-7) mm in the WL group (P = .01). The median (interquartile range) resection volume was 85.0 (60-128) cm(3) in the SHG group vs 143.4 (54-229) cm(3) in the WL group (P = .048). The median (interquartile range) resection index was 77.1 (51-220) in the SHG group vs 315.9 (89-3025) in the WL group (P = .003). The margin was revised in 1 (3.4%) of the patients who underwent SHG lumpectomy vs 5 (14.7%) of the patients who underwent WL lumpectomy (P = .20). CONCLUSIONS: Sonographic hematoma-guided lumpectomy is superior to WL lumpectomy in obtaining adequate margins while minimizing the volume of resection.