Among women eligible for supplemental MRI screening according to state insurance law, adding contrast-enhanced mammography to digital breast tomosynthesis significantly increased early breast cancer detection alongside a 13% increase in the false-positive rate.

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.

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.

Objective: For breast US interpretation, to assess impact of computer-aided diagnosis (CADx) in original mode or with improved sensitivity or specificity. Methods: In this IRB approved protocol, orthogonal-paired US images of 319 lesions identified on screening, including 88 (27.6%) cancers (median 7 mm, range 1-34 mm), were reviewed by 9 breast imaging radiologists. Each observer provided BI-RADS assessments (2, 3, 4A, 4B, 4C, 5) before and after CADx in a mode-balanced design: mode 1, original CADx (outputs benign, probably benign, suspicious, or malignant); mode 2, artificially-high-sensitivity CADx (benign or malignant); and mode 3, artificially-high-specificity CADx (benign or malignant). Area under the receiver operating characteristic curve (AUC) was estimated under each modality and for standalone CADx outputs. Multi-reader analysis accounted for inter-reader variability and correlation between same-lesion assessments. Results: AUC of standalone CADx was 0.77 (95% CI: 0.72-0.83). For mode 1, average reader AUC was 0.82 (range 0.76-0.84) without CADx and not significantly changed with CADx. In high-sensitivity mode, all observers' AUCs increased: average AUC 0.83 (range 0.78-0.86) before CADx increased to 0.88 (range 0.84-0.90), P < 0.001. In high-specificity mode, all observers' AUCs increased: average AUC 0.82 (range 0.76-0.84) before CADx increased to 0.89 (range 0.87-0.92), P < 0.0001. Radiologists responded more frequently to malignant CADx cues in high-specificity mode (42.7% vs 23.2% mode 1, and 27.0% mode 2, P = 0.008). Conclusion: Original CADx did not substantially impact radiologists' interpretations. Radiologists showed improved performance and were more responsive when CADx produced fewer false-positive malignant cues.

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.

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 Actqualified 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. Interradiologist agreement was similar for recall recommendations from DBT (kappa = 0.24, CI: 0.14-0.34) and ABUS (kappa = 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.

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.

Interpretations of breast ultrasound screening examinations result in high recall rates and large inter-radiologist variability, frequently leading to “conservative” recommendations. Double reading of all breast ultrasound screening examinations is cost prohibitive, but double reading of only “initially recalled” cases may prove efficacious. We assessed changes in recommendations, if any, by providing a consensus second opinion in a limited subset of examinations initially recommended for recall. We performed a retrospective reader study with 197 ultrasound examinations (97 not recalled and 100 recalled clinically). First, we generated a consensus “second opinion” consisting of the majority vote of three independent readings of each case by experienced ultrasound interpreters. During the reader study that followed, if the reader recommended a “recall” and the “consensus second opinion” did not, a message to that effect was displayed and the reader was asked to re-review the exam and re-assess if, knowing the second opinion, a re-rating of the case was warranted. We compared performance levels pre- and post- the second opinion. The second opinion resulted in “no recall” recommendations of 141 cases in the entire set, including four cancer cases missed by all three readers. On average, radiologists received “warning” messages in 30 cases (range 15-50), or in ~15% of cases. Rating changes (downgrades to no recall) occurred in 36 of these cases. These changes resulted in a possible recall rate reduction of 28% in prompted cases or 14% overall recall reduction, while increasing the false negative rate by only one case missed by 2 readers (~1%).

There are no data on the effect of disease prevalence during training for interpreting digital breast tomosynthesis (DBT) based screening examinations on the performance of residents and fellows. We assessed the performance of six residents (four after one breast imaging rotation and two after two rotations) and two fellows in breast imaging when interpreting DBT screening examinations in a multi-case, mode balanced, test-train-test retrospective reader study (127 training and 160 testing cases). Half were trained with feedback of verified truth after reviewing each case with low prevalence of disease (13/127) and half with high prevalence (52/128). The pre- and post-training dataset was the same. Performance measures were compared (sensitivity, specificity and AUC). Readers trained with the low prevalence set decreased the overall recall rate of non-cancer cases (FPF from 0.21 to 0.13, p<0.001), and of cases with known malignancies (TPF from 0.70 to 0.61, p=0.004, due primarily to one clearly outlier reader). Readers trained with the high prevalence increased the overall recall rate (albeit, not statistically significant) of non-cancer cases (FPF from 0.16 to 0.18, p=0.07), and a borderline significant increase of cancer cases (TPF from 0.61 to 0.66, p=0.04). Fellows post six months of specialty training in each group had no significant changes in sensitivity, specificity, or AUC after training (smallest p>0.07). Both residents with two rotations experience had significant changes in sensitivity and specificity (highest p<0.028), but not in AUC. Early training with low disease prevalence of "what not to recall" should be included during training.

The transition from FFDM to digital breast tomosynthesis (DBT) necessitates new approaches for training radiology residents and fellows that highlight depiction differences between the same abnormalities on the two modalities. We developed a unique, flexible training module that enables training with complete feedback, as well as testing performance before and after use of this training module. Currently, 219 examinations, with priors and other relevant information, are included. Using a special interface to the Secure View workstation (Hologic), we developed a management program that displays each case in a randomized manner and in a sequential mode (i.e. FFDM first followed by FFDM+DBT) and allows the reader to rate the case followed by viewing the images side by side with results of the full imaging based history (reporting) by the screening interpreter, the diagnostic workup interpreter (when applicable), and the actual pathology (biopsy and/or surgical). This approach allows the reader to review their correct and/or incorrect interpretation at each step of the management decision making. The module also has sets of pre- and post-training cases, allowing for a test-train-test study to be performed, if so desired. Two observer studies using 18 radiologists, residents, and fellows have been performed using this module, to date. The training module was assembled, tested, and implemented. We found it to be extremely flexible and useful in training. After completing two observer performance studies, the module was installed in our clinical facility and is currently being used to train residents and fellows at their own pace. All users found this module to be useful and extremely informative.

Performance changes in a binary environment when using additional information is affected only when changes in recommendations are made due to the additional information in question. In a recent study, we have shown that, contrary to general expectation, introducing prior examinations improved recall rates, but not sensitivity. In this study, we assessed cancer detection differences when prior examinations and/or digital breast tomosynthesis (DBT) were made available to the radiologist. We identified a subset of 21 cancer cases with differences in the number of radiologists who recalled these cases after reviewing either a prior examination or DBT. For the cases with differences in recommendations after viewing either priors or DBT, separately, we evaluated the total number of readers that changed their recommendations, regardless of the specific radiologist in question. Confidence intervals for the number of readers and a test for the hypothesis of no difference was performed using the non-parameteric bootstrap approach addressing both case and reader-related sources of variability by resampling cases and readers. With the addition of priors, there were 14 cancer cases (out of 15) where the number of "recalling radiologists" decreased. With the addition of DBT, the number of "recalling radiologists" decreased in only five cases (out of 15) while increasing in the remaining 9 cases. Unlike most new approaches to breast imaging DBT seems to improve both recall rates and cancer detection rates. Changes in recommendations were noted by all radiologists for all cancers by type, size, and breast density.

2619 Objectives To evaluate the impact of cadmium zinc telluride (CZT) dual detector molecular breast imaging (MBI) examination on patients scheduled for biopsy based on suspicious mammogram and/or ultrasound findings. Methods We evaluated 60 patients who were recommended to undergo stereotactic and/or ultrasound guided biopsies (BIRADS 4 or 5) using the GE Discovery NM 750b CZT dual head detector molecular breast imaging system. Each patient was injected with ~8 mCi Tc-99m Sestamibi intravenously. Images were obtained for 10 minutes a view in standard CC and MLO projections; occasionally additional images were obtained to include the entire breast. Patient biopsies were performed after the MBI examination. Results The 60 women had 73 indeterminate lesions including 48 masses and 25 calcifications identified. There were 20 pathologically confirmed cancers, 11 high risk lesions and 42 benign lesions. Of the 20 pathologically confirmed cancers, 14 were invasive cancer and 6 were DCIS associated with calcifications. 11 of the 14 invasive cancers demonstrated marked uptake, 2 with moderate uptake and 1 with mild uptake. The 5 cases of DCIS showed mild activity and one negative activity. The 11 high risk lesions demonstrated a range of negative to marked uptake. The remaining cases of benign disease demonstrated negative uptake in 27, mild uptake in 10 and moderate uptake in 5. In addition, management of three cases was directly influenced by the MBI results. Conclusions MBI with CZT dual detectors with improved image resolution and smaller pixel size offers an easy to perform, reproducible, office based exam for the workup of indeterminate findings on mammogram and/or ultrasound.

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 [DC]) 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.

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.

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 mamma graphic interpretations.

The FDA recently approved Digital Breast Tomosynthesis (DBT) for use in screening for the early detection of breast cancer. However, MQSA qualification for interpreting DBT through training was noted as important. Performance issues related to training are largely unknown. Therefore, we assembled a unique computerized training module to assess radiologists' performances before and after using the training module. Seventy-one actual baseline mammograms (no priors) with FFDM and DBT images were assembled to be read before and after training with the developed module. Fifty examinations of FFDM and DBT images enriched with positive findings were assembled for the training module. Depicted findings were carefully reviewed, summarized, and entered into a specially designed training database where findings were identified by case number and synchronized to the display of the related FFDM plus DBT examinations on a clinical workstation. Readers reported any findings using screening BIRADS (0, 1, or 2) followed by instantaneous feedback of the verified truth. Six radiologists participated in the study and reader average sensitivity and specificity were compared before and after training. Average sensitivity improved and specificity remained relatively the same after training. Performance changes may be affected by disease prevalence in the training set.

OBJECTIVE:The purpose of our study was to assess diagnostic performance when retrospectively interpreting full-field digital mammography (FFDM) and breast tomosynthesis examinations under a free-response receiver operating characteristic (FROC) paradigm.MATERIALS AND METHODS:We performed FROC analysis of a previously reported study in which eight experienced radiologists interpreted 125 examinations, including 35 with verified cancers. The FROC paradigm involves detecting, locating, and rating each suspected abnormality. Radiologists reviewed and rated both FFDM alone and a combined display mode of FFDM and digital breast tomosynthesis (DBT) (combined). Observer performance levels were assessed and compared with respect to the fraction of correctly identified abnormalities, the number of reported location-specific findings (both true and false), and their associated ratings. The analysis accounts for the number and locations of findings and the location-based ratings using a summary performance index (Λ), which is the FROC analog of the area between the receiver operating characteristic curve and the diagonal (chance) line.RESULTS:Under the FROC paradigm, each reader detected more true abnormalities associated with cancer, or a higher true-positive fraction, under the combined mode. In an analysis focused on both the number of findings and associated location-based ratings, each of the radiologists performed better under the combined mode compared with FFDM alone, with increases in Λ ranging from 5% to 34%. On average, under the combined mode radiologists achieved a 16% improvement in Λ compared with the FFDM alone mode (95% CI, 7-26%; p < 0.01).CONCLUSION:We showed that DBT-based breast imaging in combination with FFDM could result in better performance under the FROC paradigm.

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.

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.