Addition of Contrast-enhanced Mammography to Tomosynthesis for Breast Cancer Detection in Women with a Personal History of Breast Cancer: Prospective TOCEM Trial Interim Analysis.

Background Digital breast tomosynthesis (DBT) is often inadequate for screening women with a personal history of breast cancer (PHBC). The ongoing prospective Tomosynthesis or Contrast-Enhanced Mammography, or TOCEM, trial includes three annual screenings with both DBT and contrast-enhanced mammography (CEM). Purpose To perform interim assessment of cancer yield, stage, and recall rate when CEM is added to DBT in women with PHBC. Materials and Methods From October 2019 to December 2022, two radiologists interpreted both examinations: Observer 1 reviewed DBT first and then CEM, and observer 2 reviewed CEM first and then DBT. Effects of adding CEM to DBT on incremental cancer detection rate (ICDR), cancer type and node status, recall rate, and other performance characteristics of the primary radiologist decisions were assessed. Results Among the participants (mean age at entry, 63.6 years ± 9.6 [SD]), 1273, 819, and 227 women with PHBC completed year 1, 2, and 3 screening, respectively. For observer 1, year 1 cancer yield was 20 of 1273 (15.7 per 1000 screenings) for DBT and 29 of 1273 (22.8 per 1000 screenings; ICDR, 7.1 per 1000 screenings [95% CI: 3.2, 13.4]) for DBT plus CEM (P < .001). Year 2 plus 3 cancer yield was four of 1046 (3.8 per 1000 screenings) for DBT and eight of 1046 (7.6 per 1000 screenings; ICDR, 3.8 per 1000 screenings [95% CI: 1.0, 7.6]) for DBT plus CEM (P = .001). Year 1 recall rate for observer 1 was 103 of 1273 (8.1%) for (incidence) DBT alone and 187 of 1273 (14.7%) for DBT plus CEM (difference = 84 of 1273, 6.6% [95% CI: 5.3, 8.1]; P < .001). Year 2 plus 3 recall rate was 40 of 1046 (3.8%) for DBT and 92 of 1046 (8.8%) for DBT plus CEM (difference = 52 of 1046, 5.0% [95% CI: 3.7, 6.3]; P < .001). In 18 breasts with cancer detected only at CEM after integration of both observers, 13 (72%) cancers were invasive (median tumor size, 0.6 cm) and eight of nine (88%) with staging were N0. Among 1883 screenings with adequate reference standard, there were three interval cancers (one at the scar, two in axillae). Conclusion CEM added to DBT increased early breast cancer detection each year in women with PHBC, with an accompanying approximately 5.0%-6.6% recall rate increase. Clinical trial registration no. NCT04085510 © RSNA, 2024 Supplemental material is available for this article.

Prospective Multicenter Diagnostic Performance of Technologist-Performed Screening Breast Ultrasound After Tomosynthesis in Women With Dense Breasts (the DBTUST).

PURPOSE: To assess diagnostic performance of digital breast tomosynthesis (DBT) alone or combined with technologist-performed handheld screening ultrasound (US) in women with dense breasts. METHODS: In an institutional review board-approved, Health Insurance Portability and Accountability Act-compliant multicenter protocol in western Pennsylvania, 6,179 women consented to three rounds of annual screening, interpreted by two radiologist observers, and had appropriate follow-up. Primary analysis was based on first observer results. RESULTS: Mean participant age was 54.8 years (range, 40-75 years). Across 17,552 screens, there were 126 cancer events in 125 women (7.2/1,000; 95% CI, 5.9 to 8.4). In year 1, DBT-alone cancer yield was 5.0/1,000, and of DBT+US, 6.3/1,000, difference 1.3/1,000 (95% CI, 0.3 to 2.1; P = .005). In years 2 + 3, DBT cancer yield was 4.9/1,000, and of DBT+US, 5.9/1,000, difference 1.0/1,000 (95% CI, 0.4 to 1.5; P < .001). False-positive rate increased from 7.0% for DBT in year 1 to 11.5% for DBT+US and from 5.9% for DBT in year 2 + 3 to 9.7% for DBT+US (P < .001 for both). Nine cancers were seen only by double reading DBT and one by double reading US. Ten interval cancers (0.6/1,000 [95% CI, 0.2 to 0.9]) were identified. Despite reduction in specificity, addition of US improved receiver operating characteristic curves, with area under receiver operating characteristic curve increasing from 0.83 for DBT alone to 0.92 for DBT+US in year 1 (P = .01), with smaller improvements in subsequent years. Of 6,179 women, across all 3 years, 172/6,179 (2.8%) unique women had a false-positive biopsy because of DBT as did another 230/6,179 (3.7%) women because of US (P < .001). CONCLUSION: Overall added cancer detection rate of US screening after DBT was modest at 19/17,552 (1.1/1,000; CI, 0.5- to 1.6) screens but potentially overcomes substantial increases in false-positive recalls and benign biopsies.

Contrast-enhanced Mammography-guided Biopsy: Initial Trial and Experience.

OBJECTIVE: Evaluate lesion visibility and radiologist confidence during contrast-enhanced mammography (CEM)-guided biopsy. METHODS: Women with BI-RADS ≥4A enhancing breast lesions were prospectively recruited for 9-g vacuum-assisted CEM-guided biopsy. Breast density, background parenchymal enhancement (BPE), lesion characteristics (enhancement and conspicuity), radiologist confidence (scale 1-5), and acquisition times were collected. Signal intensities in specimens were analyzed. Patient surveys were collected. RESULTS: A cohort of 28 women aged 40-81 years (average 57) had 28 enhancing lesions (7/28, 25% malignant). Breast tissue was scattered (10/28, 36%) or heterogeneously dense (18/28, 64%) with minimal (12/28, 43%), mild (7/28, 25%), or moderate (9/28, 32%) BPE on CEM. Twelve non-mass enhancements, 11 masses, 3 architectural distortions, and 2 calcification groups demonstrated weak (12/28, 43%), moderate (14/28, 50%), or strong (2/28, 7%) enhancement. Specimen radiography demonstrated lesion enhancement in 27/28 (96%). Radiologists reported complete lesion removal on specimen radiography in 8/28 (29%). Average time from contrast injection to specimen radiography was 18 minutes (SD = 5) and, to post-procedure mammogram (PPM), 34 minutes (SD = 10). Contrast-enhanced mammography PPM was performed in 27/28 cases; 13/19 (68%) of incompletely removed lesions on specimen radiography showed residual enhancement; 6/19 (32%) did not. Across all time points, average confidence was 2.2 (SD = 1.2). Signal intensities of enhancing lesions were similar to iodine. Patients had an overall positive assessment. CONCLUSION: Lesion enhancement persisted through PPM and was visible on low energy specimen radiography, with an average "confident" score. Contrast-enhanced mammography-guided breast biopsy is easily implemented clinically. Its availability will encourage adoption of CEM.

Contrast Enhanced Digital Mammography (CEDM) Helps to Safely Reduce Benign Breast Biopsies for Low to Moderately Suspicious Soft Tissue Lesions.

RATIONALE AND OBJECTIVES: To preliminarily asses if Contrast Enhanced Digital Mammography (CEDM) can accurately reduce biopsy rates for soft tissue BI-RADS 4A or 4B lesions. MATERIALS AND METHODS: Eight radiologists retrospectively and independently reviewed 60 lesions in 54 consenting patients who underwent CEDM under Health Insurance Portability and Accountability Act compliant institutional review board-approved protocols. Readers provided Breast Imaging Reporting & Data System ratings sequentially for digital mammography/digital breast tomosynthesis (DM/DBT), then with ultrasound, then with CEDM for each lesion. Area under the curve (AUC), true positive rates and false positive rates, positive predictive values and negative predictive values were calculated. Statistical analysis accounting for correlation between lesion-examinations and between-reader variability was performed using OR/DBM (for SAS v.3.0), generalized linear mixed model for binary data (proc glimmix, SAS v.9.4, SAS Institute, Cary North Carolina), and bootstrap. RESULTS: The cohort included 49 benign, two high-risk and nine cancerous lesions in 54 women aged 34-74 (average 50) years. Reader-averaged AUC for CEDM was significantly higher than DM/DBT alone (0.85 versus 0.66, p < 0.001) or with US (0.85 versus 0.75, p = 0.001). CEDM increased true positive rates from 0.74 under DB/DBT, and 0.89 with US, to 0.90 with CEDM, (p = 0.019 DM/DBT versus CEDM, p = 0.78 DM/DBT + US versus CEDM) and decreased false positive rates from 0.47 using DM/DBT and 0.61 with US to 0.39 with CEDM (p = 0.017 DM/DBT versus CEDM, p = 0.001 DM/DBT+ US versus CEDM). For an expected cancer rate of 10%, CEDM positive predictive values was 20.5% (95% CI: 16%-27%) and negative predictive values 98.3% (95% CI: 96%-100%). CONCLUSION: Addition of CEDM for evaluation of low-moderate suspicion soft tissue breast lesions can substantially reduce biopsy of benign lesions without compromising cancer detection.

A Prospective Study of Automated Breast Ultrasound Screening of Women with Dense Breasts in a Digital Breast Tomosynthesis-based Practice.

OBJECTIVE: To assess prospectively the interpretative performance of automated breast ultrasound (ABUS) as a supplemental screening after digital breast tomosynthesis (DBT) or as a standalone screening of women with dense breast tissue. METHODS: Under an IRB-approved protocol (written consent required), women with dense breasts prospectively underwent concurrent baseline DBT and ABUS screening. Examinations were independently evaluated, in opposite order, by two of seven Mammography Quality Standards Act-qualified radiologists, with the primary radiologist arbitrating disagreements and making clinical management recommendations. We report results for 1111 screening examinations (598 first year and 513 second year) for which all diagnostic workups are complete. Imaging was also retrospectively reviewed for all cancers. Statistical assessments used a 0.05 significance level and accounted for correlation between participants' examinations. RESULTS: Of 1111 women screened, primary radiologists initially "recalled" based on DBT alone (6.6%, 73/1111, CI: 5.2%-8.2%), of which 20 were biopsied, yielding 6/8 total cancers. Automated breast ultrasound increased recalls overall to 14.4% (160/1111, CI: 12.4%-16.6%), with 27 total biopsies, yielding 1 additional cancer. Double reading of DBT alone increased the recall rate to 10.7% (119/1111), with 21 biopsies, with no improvement in cancer detection. Double reading ABUS increased the recall rate to 15.2% (169/1111, CI: 13.2%-17.5%) of women, of whom 22 were biopsied, yielding the detection of 7 cancers, including one seen only on double reading ABUS. Inter-radiologist agreement was similar for recall recommendations from DBT (κ = 0.24, CI: 0.14-0.34) and ABUS (κ = 0.23, CI: 0.15-0.32). Integrated assessments from both readers resulted in a recall rate of 15.1% (168/1111, CI: 13.1%-17.4%). CONCLUSION: Supplemental or standalone ABUS screening detected cancers not seen on DBT, but substantially increased noncancer recall rates.

Diagnostic Performance of MRI, Molecular Breast Imaging, and Contrast-enhanced Mammography in Women with Newly Diagnosed Breast Cancer.

Background Staging newly diagnosed breast cancer by using dynamic contrast material-enhanced MRI is limited by access, high cost, and false-positive findings. The utility of contrast-enhanced mammography (CEM) and 99mTc sestamibi-based molecular breast imaging (MBI) in this setting is largely unknown. Purpose To compare extent-of-disease assessments by using MRI, CEM, and MBI versus pathology in women with breast cancer. Materials and Methods In this HIPAA-compliant prospective study, women with biopsy-proven breast cancer underwent MRI, CEM, and MBI between October 2014 and April 2018. Eight radiologists independently interpreted each examination result prospectively and were blinded to interpretations of findings with the other modalities. Visibility of index malignancies, lesion size, and additional suspicious lesions (malignant or benign) were compared during pathology review. Accuracy of index lesion sizing and detection of additional lesions in women without neoadjuvant chemotherapy were compared. Results A total of 102 women were enrolled and 99 completed the study protocol (mean age, 51 years ± 11 [standard deviation]; range, 32-77 years). Lumpectomy or mastectomy was performed in 71 women (79 index malignancies) without neoadjuvant chemotherapy and in 28 women (31 index malignancies) with neoadjuvant chemotherapy. Of the 110 index malignancies, MRI, CEM, and MBI depicted 102 (93%; 95% confidence interval [CI]: 86%, 97%), 100 (91%; 95% CI: 84%, 96%), and 101 (92%; 95% CI: 85%, 96%) malignancies, respectively. In patients without neoadjuvant chemotherapy, pathologic size of index malignancies was overestimated with all modalities (P = .02). MRI led to overestimation of 24% (17 of 72) of malignancies by more than 1.5 cm compared with 11% (eight of 70) with CEM and 15% (11 of 72) with MBI. MRI depicted more (P = .007) nonindex lesions, with sensitivity similar to that of CEM or MBI, resulting in lower positive predictive value of additional biopsies (13 of 46 [28%; 95% CI: 17%, 44%] for MRI; 14 of 27 [52%; 95% CI: 32%, 71%] for CEM; and 11 of 25 [44%; 95% CI: 24%, 65%] for MBI (overall P = .01). Conclusion Contrast-enhanced mammography, molecular breast imaging, and MRI showed similar detection of all malignancies. MRI depicted more nonindex suspicious benign lesions than did contrast-enhanced mammography or molecular breast imaging, leading to lower positive predictive value of additional biopsies. All three modalities led to overestimation of index tumor size, particularly MRI. © RSNA, 2019 Online supplemental material is available for this article.

Recall Rate Reduction with Tomosynthesis During Baseline Screening Examinations: An Assessment From a Prospective Trial.

RATIONALE AND OBJECTIVES: Assess results of a prospective, single-site clinical study evaluating digital breast tomosynthesis (DBT) during baseline screening mammography. MATERIALS AND METHODS: Under an institutional review board-approved Health Insurance Portability and Accountability Act (HIPAA)-compliant protocol, consenting women between ages 34 and 56 years scheduled for their initial and/or baseline screening mammogram underwent both full field digital mammography (FFDM) and DBT. The FFDM and the FFDM plus DBT images were interpreted independently in a reader by mode balanced approach by two of 14 participating radiologists. A woman was recalled for a diagnostic work-up if either radiologist recommended a recall. We report overall recall rates and related diagnostic outcome from the 1080 participants. Proportion of recommended recalls (Breast Imaging Reporting and Data System 0) were compared using a generalized linear mixed model (SAS 9.3) with a significance level of P = .0294. RESULTS: The fraction of women without breast cancer recommended for recall using FFDM alone and FFDM plus DBT were 412 of 1074 (38.4%) and 274 of 1074 (25.5%), respectively (P < .001). Large inter-reader variability in terms of recall reduction was observed among the 14 readers; however, 11 of 14 readers recalled fewer women using FFDM plus DBT (5 with P < .015). Six cancers (four ductal carcinomas in situ [DCIS] and two invasive ductal carcinomas [IDC]) were detected. One IDC was detected only on DBT and one DCIS cancer was detected only on FFDM, whereas the remaining cancers were detected on both modalities. CONCLUSIONS: The use of FFDM plus DBT resulted in a significant decrease in recall rates during baseline screening mammography with no reduction in sensitivity.

Radioactive seed localization versus wire localization for lumpectomies: a comparison of outcomes.

OBJECTIVE: The purpose of this study was to compare outcomes of radioactive seed localization (RSL) versus wire localization using surgical margin size, reexcision and reoperation rates, specimen size, radiology resource utilization, and cosmesis as measures. MATERIALS AND METHODS: Patients who underwent RSL before segmental mastectomy from April 1, 2011, to March 1, 2012, for biopsy-proven cancer were selected. Each was matched using tumor size, type, and surgeon to a wire localization control case, resulting in 232 cases. Width of the closest surgical margin, reexcision rate, and reoperation rate were compared as were the ratios of tumor volume to initial surgical specimen volume and tumor volume to all surgically excised volume (including reexcisions and reoperations). Cosmetic outcome was analyzed by comparison of Harvard scores and specimen volume with breast volume. Radiology resource utilization was compared before and after RSL implementation. RESULTS: No significant differences between methods were found in closest surgical margin (RSL mean, 0.45 cm; wire localization mean, 0.45 cm; p=0.972), reexcision rate (RSL mean, 21.1%; wire localization mean, 26.3%; p=0.360), reoperation rate (RSL, 11.4%; wire localization, 12.7%; p=0.841), ratio of the tumor volume to initial surgical specimen volume (RSL mean, 0.027; wire localization mean, 0.028; p=0.886), ratio of the tumor volume to total volume resected (RSL mean, 0.024; wire localization mean, 0.024; p=0.997), or in clinical or computed cosmesis scores (clinical p=0.5; calculated p=0.060). There was a 34% increase in scheduled biopsy slot utilization, 50% savings in time spent scheduling, and a 4.1-day average decrease in biopsy wait time after RSL institution. CONCLUSION: RSL is an acceptable alternative to wire localization and offers significant improvements in workflow.

Effect of the Availability of Prior Full-Field Digital Mammography and Digital Breast Tomosynthesis Images on the Interpretation of Mammograms.

PURPOSE: To assess the effect of and interaction between the availability of prior images and digital breast tomosynthesis (DBT) images in decisions to recall women during mammogram interpretation. MATERIALS AND METHODS: Verbal informed consent was obtained for this HIPAA-compliant institutional review board-approved protocol. Eight radiologists independently interpreted twice deidentified mammograms obtained in 153 women (age range, 37-83 years; mean age, 53.7 years ± 9.3 [standard deviation]) in a mode by reader by case-balanced fully crossed study. Each study consisted of current and prior full-field digital mammography (FFDM) images and DBT images that were acquired in our facility between June 2009 and January 2013. For one reading, sequential ratings were provided by using (a) current FFDM images only, (b) current FFDM and DBT images, and (c) current FFDM, DBT, and prior FFDM images. The other reading consisted of (a) current FFDM images only, (b) current and prior FFDM images, and (c) current FFDM, prior FFDM, and DBT images. Fifty verified cancer cases, 60 negative and benign cases (clinically not recalled), and 43 benign cases (clinically recalled) were included. Recall recommendations and interaction between the effect of prior FFDM and DBT images were assessed by using a generalized linear model accounting for case and reader variability. RESULTS: Average recall rates in noncancer cases were significantly reduced with the addition of prior FFDM images by 34% (145 of 421) and 32% (106 of 333) without and with DBT images, respectively (P < .001). However, this recall reduction was achieved at the cost of a corresponding 7% (23 of 345) and 4% (14 of 353) reduction in sensitivity (P = .006). In contrast, availability of DBT images resulted in a smaller reduction in recall rates (false-positive interpretations) of 19% (76 of 409) and 26% (71 of 276) without and with prior FFDM images, respectively (P = .001). Availability of DBT images resulted in 4% (15 of 338) and 8% (25 of 322) increases in sensitivity, respectively (P = .007). The effects of the availability of prior FFDM images or DBT images did not significantly change regardless of the sequence in presentation (P = .81 and P = .47 for specificity and sensitivity, respectively). CONCLUSION: The availability of prior FFDM or DBT images is a largely independent contributing factor in reducing recall recommendations during mammographic interpretation.

Ultrasound Guided Core Biopsy versus Fine Needle Aspiration for Evaluation of Axillary Lymphadenopathy in Patients with Breast Cancer.

Rationale and Objectives. To compare the sensitivities of ultrasound guided core biopsy and fine needle aspiration (FNA) for detection of axillary lymph node metastases in patients with a current diagnosis of ipsilateral breast cancer. Materials and Methods. From December 2008 to December 2010, 105 patients with breast cancer and abnormal appearing lymph nodes in the ipsilateral axilla consented to undergo FNA of an axillary node immediately followed by core biopsy of the same node, both with ultrasound guidance. Experienced pathologists evaluated the aspirate cytology without knowledge of the core histology. Cytology and core biopsy results were compared to sentinel node excision or axillary dissection pathology. Sensitivities were compared using McNemar's test. Results. Of 70 patients with axillary node metastases, FNA was positive in 55/70 (78.6%) and core was positive in 61/70 (87.1%) (P = 0.18). The FNA and core results were discordant in 14/70 (20%) patients. Ten cases were FNA negative/core positive. Four cases were FNA positive/core negative. Conclusion. Core biopsy detected six (8.6%) more cases of metastatic lymphadenopathy than FNA but the difference in sensitivities was not statistically significant. Core biopsy should be considered if the node is clearly imaged and readily accessible. FNA is a good alternative when a smaller needle is desired due to node location or other patient factors. This trial is registered with NCT01920139.

Impact of and interaction between the availability of prior examinations and DBT on the interpretation of negative and benign mammograms.

RATIONALE AND OBJECTIVES: To assess the interaction between the availability of prior examinations and digital breast tomosynthesis (DBT) in decisions to recall a woman during interpretation of mammograms. MATERIALS AND METHODS: Eight radiologists independently interpreted twice 36 mammography examinations, each of which had current and prior full-field digital mammography images (FFDM) and DBT under a Health Insurance Portability and Accountability Act-compliant, institutional review board-approved protocol (written consent waived). During the first reading, three sequential ratings were provided using FFDM only, followed by FFDM + DBT, and then followed by FFDM + DBT + priors. The second reading included FFDM only, then FFDM + priors, and then FFDM + priors + DBT. Twenty-two benign cases clinically recalled, 12 negative/benign examinations (not recalled), and two verified cancer cases were included. Recall recommendations and interaction between the effect of priors and DBT on decisions were assessed (P = .05 significance level) using generalized linear model (PROC GLIMMIX, SAS, version 9.3; SAS Institute, Cary, NC) accounting for case and reader variability. RESULTS: Average recall rates in noncancer cases were significantly reduced (51%; P < .001) with the addition of DBT and with addition of priors (23%; P = .01). In absolute terms, the addition of DBT to FFDM reduced the recall rates from 0.67 to 0.42 and from 0.54 to 0.27 when DBT was available before and after priors, respectively. Recall reductions were from 0.64 to 0.54 and from 0.42 to 0.33 when priors were available before and after DBT, respectively. Regardless of the sequence in presentation, there were no statistically significant interactions between the effect of availability of DBT and priors (P = .80). CONCLUSIONS: Availability of both priors and DBT are independent primary factors in reducing recall recommendations during mammographic interpretations.

Frequency of carcinoma at secondary imaging-guided percutaneous breast biopsy performed after a high-risk pathologic result at primary biopsy.

OBJECTIVE: The purpose of this study was to determine the frequency of carcinoma identified with secondary presurgical imaging-guided percutaneous biopsy for patients with high-risk pathologic findings at primary percutaneous biopsy. MATERIALS AND METHODS: A retrospective computerized search of our breast imaging database from January 1, 2005, to October 1, 2010, was conducted to identify the cases of patients with high-risk pathologic findings at primary biopsy who underwent at least one secondary biopsy within 9 months and underwent surgical excision. Lesion type, location, biopsy guidance, device, number of samples, and histopathologic findings were recorded. The pathologic findings at surgical excision were compared with the percutaneous biopsy results. RESULTS: One hundred twenty-three patients underwent 158 secondary biopsies. On average, 1.3 additional biopsies were performed per patient. Among the 158 secondary biopsies, 105 (66.4%) had benign, 48 (30.4%) had high-risk, and five (3.2%) had malignant histopathologic findings. No malignant tumors were identified at secondary percutaneous biopsies in cases in which the same lesion type was biopsied in the same quadrant. Use of secondary percutaneous biopsy led to detection of nine malignant tumors in 7.3% of patients-with percutaneous biopsy in four (3.2%) patients and at surgical excision in five (4.1%) patients. CONCLUSION: After initial imaging-guided percutaneous biopsy reveals high-risk pathologic findings, identification of additional high-risk lesions at secondary percutaneous biopsy is common, and detection of malignancy is relatively infrequent. However, because the secondarily identified high-risk lesions are sometimes upstaged to cancer at surgical excision, additional imaging-directed biopsy has potential benefit for patients with known highrisk lesions and multiple synchronous findings.

Digital breast tomosynthesis versus supplemental diagnostic mammographic views for evaluation of noncalcified breast lesions.

PURPOSE: To compare the diagnostic performance of breast tomosynthesis versus supplemental mammography views in classification of masses, distortions, and asymmetries. MATERIALS AND METHODS: Eight radiologists who specialized in breast imaging retrospectively reviewed 217 consecutively accrued lesions by using protocols that were HIPAA compliant and institutional review board approved in 182 patients aged 31-60 years (mean, 50 years) who underwent diagnostic mammography and tomosynthesis. The lesions in the cohort included 33% (72 of 217) cancers and 67% (145 of 217) benign lesions. Eighty-four percent (182 of 217) of the lesions were masses, 11% (25 of 217) were asymmetries, and 5% (10 of 217) were distortions that were initially detected at clinical examination in 8% (17 of 217), at mammography in 80% (173 of 217), at ultrasonography (US) in 11% (25 of 217), or at magnetic resonance imaging in 1% (2 of 217). Histopathologic examination established truth in 191 lesions, US revealed a cyst in 12 lesions, and 14 lesions had a normal follow-up. Each lesion was interpreted once with tomosynthesis and once with supplemental mammographic views; both modes included the mediolateral oblique and craniocaudal views in a fully crossed and balanced design by using a five-category Breast Imaging Reporting and Data System (BI-RADS) assessment and a probability-of-malignancy score. Differences between modes were analyzed with a generalized linear mixed model for BI-RADS-based sensitivity and specificity and with modified Obuchowski-Rockette approach for probability-of-malignancy-based area under the receiver operating characteristic (ROC) curve. RESULTS: Average probability-of-malignancy-based area under the ROC curve was 0.87 for tomosynthesis versus 0.83 for supplemental views (P < .001). With tomosynthesis, the false-positive rate decreased from 85% (989 of 1160) to 74% (864 of 1160) (P < .01) for cases that were rated BI-RADS category 3 or higher and from 57% (663 of 1160) to 48% (559 of 1160) for cases rated BI-RADS category 4 or 5 (P < .01), without a meaningful change in sensitivity. With tomosynthesis, more cancers were classified as BI-RADS category 5 (39% [226 of 576] vs 33% [188 of 576]; P = .017) without a decrease in specificity. CONCLUSION: Tomosynthesis significantly improved diagnostic accuracy for noncalcified lesions compared with supplemental mammographic views.

Risk of malignancy when microscopic radial scars and microscopic papillomas are found at percutaneous biopsy.

OBJECTIVE: The objective of our study was to assess the incidence of associated malignancy when microscopic radial scars and microscopic intraductal papillomas are encountered at percutaneous biopsy for lesions that otherwise reveal benign histopathology. MATERIALS AND METHODS: A search of the pathology database for the period from December 14, 2006, through December 21, 2009, identified patients with a microscopic radial scar, a microscopic intraductal papilloma, or both at percutaneous biopsy. Patients whose percutaneous biopsy was performed for a lesion that revealed carcinoma or a high-risk pathology result were excluded to avoid confounding bias, as were patients who had only imaging follow-up. Only patients who underwent surgery solely for the study lesion were included. The lesion type that prompted core biopsy, biopsy guidance and device, sample number, and surgical outcomes were recorded. The incidences of benign, high-risk, and malignant pathology findings from surgery were calculated. RESULTS: The search revealed 35 patients (18 microscopic radial scars, 17 microscopic papillomas) who underwent surgery solely for the study lesion. Stereotactic guidance was used for 15 (43%); ultrasound, for 12 (34%); and MRI, for eight (23%). At surgery, 12 patients (34%) had high-risk histopathology results and 23 (66%) had benign results. No study lesions were upgraded to malignancy. CONCLUSION: Our study found no evidence of associated malignancy at surgical excision when microscopic radial scars and microscopic intraductal papillomas were encountered at percutaneous biopsy in patients who otherwise had benign histopathology results; thus, routine imaging follow-up may be performed.

Dose reduction in digital breast tomosynthesis (DBT) screening using synthetically reconstructed projection images: an observer performance study.

RATIONALE AND OBJECTIVES: The aim of this study was to retrospectively compare the interpretive performance of synthetically reconstructed two-dimensional images in combination with digital breast tomosynthesis (DBT) versus full-field digital mammography (FFDM) plus DBT. MATERIALS AND METHODS: Ten radiologists trained in reading tomosynthesis examinations interpreted retrospectively, under two modes, 114 mammograms. One mode included the directly acquired full-field digital mammograms combined with DBT, and the other included synthetically reconstructed projection images combined with DBT. The reconstructed images do not require additional radiation exposure. The two modes were compared with respect to sensitivity, namely, recommendation to recall a breast with either a pathology-proven cancer (n = 48) or a high-risk lesion (n = 6), and specificity, namely, no recommendation to recall a breast not depicting an abnormality (n = 144) or depicting only benign abnormalities (n = 30). RESULTS: The average sensitivity for FFDM with DBT was 0.826, compared to 0.772 for synthetic FFDM with DBT (difference, 0.054; P = .017 and P = .053 for fixed and random reader effects, respectively). The proportions of breasts with no or benign abnormalities recommended to be recalled were virtually the same: 0.298 and 0.297 for the two modalities, respectively (95% confidence intervals for the difference, -0.028 to 0.036 and -0.070 to 0.066 for fixed and random reader effects, respectively). Sixteen additional clusters of microcalcifications ("positive" breasts) were missed by all readers combined when interpreting the mode with synthesized images versus FFDM. CONCLUSIONS: Lower sensitivity with comparable specificity was observed with the tested version of synthetically generated images compared to FFDM, both combined with DBT. Improved synthesized images with experimentally verified acceptable diagnostic quality will be needed to eliminate double exposure during DBT-based screening.

Detection and classification of calcifications on digital breast tomosynthesis and 2D digital mammography: a comparison.

OBJECTIVE: The purpose of this article is to compare the ability of digital breast tomosynthesis and full field digital mammography (FFDM) to detect and characterize calcifications. MATERIALS AND METHODS: One hundred paired examinations were performed utilizing FFDM and digital breast tomosynthesis. Twenty biopsy-proven cancers, 40 biopsy-proven benign calcifications, and 40 randomly selected negative screening studies were retrospectively reviewed by five radiologists in a crossed multireader multimodal observer performance study. Data collected included the presence of calcifications and forced BI-RADS scores. Receiver operator curve analysis using BI-RADS was performed. RESULTS: Overall calcification detection sensitivity was higher for FFDM (84% [95% CI, 79-88%]) than for digital breast tomosynthesis (75% [95% CI, 70-80%]). [corrected] In the cancer cohort, 75 (76%) of 99 interpretations identified calcification in both modes. Of those, a BI-RADS score less than or equal to 2 was rendered in three (4%) and nine (12%) cases with FFDM and digital breast tomosynthesis, respectively. In the benign cohort, 123 (62%) of 200 interpretations identified calcifications in both modes. Of those, a BI-RADS score greater than or equal to 3 was assigned in 105 (85%) and 93 (76%) cases with FFDM and digital breast tomosynthesis, respectively. There was no significant difference in the nonparametric computed area under the receiver operating characteristic curves (AUC) using the BI-RADS scores (FFDM, AUC = 0.76 and SD = 0.03; digital breast tomosynthesis, AUC = 0.72 and SD = 0.04 [p = 0.1277]). CONCLUSION: In this small data set, FFDM appears to be slightly more sensitive than digital breast tomosynthesis for the detection of calcification. However, diagnostic performance as measured by area under the curve using BI-RADS was not significantly different. With improvements in processing algorithms and display, digital breast tomosynthesis could potentially be improved for this purpose.

Digital breast tomosynthesis in the diagnostic environment: A subjective side-by-side review.

OBJECTIVE: The purpose of our study was to subjectively compare additional mammographic views to digital breast tomosynthesis (DBT) in the characterizing of known masses, architectural distortions, or asymmetries. MATERIALS AND METHODS: Four experienced radiologists serially reviewed the imaging studies of 25 women with known masses, including full-field digital mammography (FFDM), additional views, and DBT. After review of the examinations, radiologists rated their relative preference in terms of classifying the finding in question when aided by the additional views versus aided by DBT, their combined diagnostic BI-RADS rating of the finding when both examinations were available, and whether or not they felt comfortable eliminating ultrasound in the specific cases being evaluated as a result of the DBT. RESULTS: FFDM and DBT (combined) were perceived to be better for diagnosis in 50% (50/100) of the ratings (25 cases x four readers = 100 ratings) compared with FFDM and additional diagnostic views. Over all readers, 92% of the ratings for verified cancer cases and 50% of the ratings for high-risk cases were rated as BI-RADS 4 or 5. In 12% (12/100) of the ratings, radiologists indicated that the availability of DBT would have eliminated the need for ultrasound as a part of the diagnostic process. CONCLUSION: DBT may be an alternative to obtaining additional mammographic views in most but not all cases of patients with a lesion that is not solely calcifications. In a fraction of cases, the use of DBT may eliminate the need for ultrasound.

Is an ROC-type response truly always better than a binary response in observer performance studies?

RATIONALE AND OBJECTIVES: The aim of this study was to assess similarities and differences between methods of performance comparisons under binary (yes or no) and receiver-operating characteristic (ROC)-type pseudocontinuous (0-100) rating data ascertained during an observer performance study of interpretation of full-field digital mammography (FFDM) versus FFDM plus digital breast tomosynthesis. MATERIALS AND METHODS: Rating data consisted of ROC-type pseudocontinuous and binary ratings generated by eight radiologists evaluating 77 digital mammographic examinations. Overall performance levels were summarized with a conventionally used probability of correct discrimination or, equivalently, the area under the ROC curve (AUC), which under a binary scale is related to Youden's index. Magnitudes of differences in the reader-averaged empirical AUCs between FFDM alone and FFDM plus digital breast tomosynthesis were compared in the context of fixed-reader and random-reader variability of the estimates. RESULTS: The absolute differences between modes using the empirical AUCs were larger on average for the binary scale (0.12 vs 0.07) and for the majority of individual readers (six of eight). Standardized differences were consistent with this finding (2.32 vs 1.63 on average). Reader-averaged differences in AUCs standardized by fixed-reader and random-reader variances were also smaller under the binary rating paradigm. The discrepancy between AUC differences depended on the location of the reader-specific binary operating points. CONCLUSIONS: The human observer's operating point should be a primary consideration in designing an observer performance study. Although in general, the ROC-type rating paradigm provides more detailed information on the characteristics of different modes, it does not reflect the actual operating point adopted by human observers. There are application-driven scenarios in which analysis based on binary responses may provide statistical advantages.

Digital breast tomosynthesis: observer performance study.

OBJECTIVE: The purpose of this study was to compare in a retrospective observer study the diagnostic performance of full-field digital mammography (FFDM) with that of digital breast tomosynthesis. MATERIALS AND METHODS: Eight experienced radiologists interpreted images from 125 selected examinations, 35 with verified findings of cancer and 90 with no finding of cancer. The four display conditions included FFDM alone, 11 low-dose projections, reconstructed digital breast tomosynthesis images, and a combined display mode of FFDM and digital breast tomosynthesis images. Observers rated examinations using the screening BI-RADS rating scale and the free-response receiver operating characteristic paradigm. Observer performance levels were measured as the proportion of examinations prompting recall of patients for further diagnostic evaluation. The results were presented in terms of true-positive fraction and false-positive fraction. Performance levels were compared among the acquisitions and reading modes. Time to view and interpret an examination also was evaluated. RESULTS: Use of the combination of digital breast tomosynthesis and FFDM was associated with 30% reduction in recall rate for cancer-free examinations that would have led to recall if FFDM had been used alone (p < 0.0001 for the participating radiologists, p = 0.047 in the context of a generalized population of radiologists). Use of digital breast tomosynthesis alone also tended to reduce recall rates, an average of 10%, although the observed decrease was not statistically significant (p = 0.09 for the participating radiologists). There was no convincing evidence that use of digital breast tomosynthesis alone or in combination with FFDM results in a substantial improvement in sensitivity. CONCLUSION: Use of digital breast tomosynthesis for breast imaging may result in a substantial decrease in recall rate.

Matching breast masses depicted on different views a comparison of three methods.

RATIONALE AND OBJECTIVES: Computerized determination of optimal search areas on mammograms for matching breast mass regions depicted on two ipsilateral views remains a challenge for developing multiview-based computer-aided detection (CAD) schemes. The purpose of this study was to compare three methods aimed at matching CAD-cued mass regions depicted on two views and the associated impact on CAD performance. MATERIALS AND METHODS: The three search methods used (1) an annular (fan-shaped) band, (2) a straight strip perpendicular to the estimated centerline, and (3) a mixed search area bound on the chest wall side by a straight line and an annular arc on the nipple side, respectively. An image database of 200 examinations with positive results depicting the masses on two views and 200 examinations with negative results was used for testing. Two performance assessment experiments were conducted. The first investigated the maximum matching sensitivity as a function of the search area size, and the second assessed the change in CAD performance using these three search methods. RESULTS: To include all 200 paired mass regions within the search areas, maximum widths were 28 and 68 mm for the use of the straight strip and the annular band search methods, respectively. When applying a single-image-based CAD scheme to this image database, 172 masses (86% sensitivity) and 523 false-positive (FP) regions (0.33 per image) were detected and cued. Among the positive findings, 92 were cued by the CAD system on both views, and 80 were cued on only one view. In an attempt to match as many of the 172 CAD-cued masses (true-positive [TP] regions) on two views by incrementally reducing the CAD threshold inside the different search areas, the CAD scheme generated 158 TP-TP paired matches with 14 TP-FP paired matches, 142 TP-TP paired matches with 30 TP-FP paired matches, and 146 TP-TP paired matches with 26 TP-FP paired matches, using the methods involving the straight strip, the annular band, and the mixed search areas, respectively. Using the straight strip search method, the CAD also eliminated 25% of FP regions initially cued by the single-image-based CAD scheme and generated the lowest case-based FP detection rate, namely, 15% less than that generated by the annular band method. CONCLUSIONS: This study showed that among these three search methods, the straight strip method required a smaller search area and achieved the highest level of CAD performance.