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.

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.

Comparison of two-dimensional synthesized mammograms versus original digital mammograms alone and in combination with tomosynthesis images.

PURPOSE: To assess interpretation performance and radiation dose when two-dimensional synthesized mammography (SM) images versus standard full-field digital mammography (FFDM) images are used alone or in combination with digital breast tomosynthesis images. MATERIALS AND METHODS: A fully crossed, mode-balanced multicase (n = 123), multireader (n = 8), retrospective observer performance study was performed by using deidentified images acquired between 2008 and 2011 with institutional review board approved, HIPAA-compliant protocols, during which each patient signed informed consent. The cohort included 36 cases of biopsy-proven cancer, 35 cases of biopsy-proven benign lesions, and 52 normal or benign cases (Breast Imaging Reporting and Data System [BI-RADS] score of 1 or 2) with negative 1-year follow-up results. Accuracy of sequentially reported probability of malignancy ratings and seven-category forced BI-RADS ratings was evaluated by using areas under the receiver operating characteristic curve (AUCs) in the random-reader analysis. RESULTS: Probability of malignancy-based mean AUCs for SM and FFDM images alone was 0.894 and 0.889, respectively (difference, -0.005; 95% confidence interval [CI]: -0.062, 0.054; P = .85). Mean AUC for SM with tomosynthesis and FFDM with tomosynthesis was 0.916 and 0.939, respectively (difference, 0.023; 95% CI: -0.011, 0.057; P = .19). In terms of the reader-specific AUCs, five readers performed better with SM alone versus FFDM alone, and all eight readers performed better with combined FFDM and tomosynthesis (absolute differences from 0.003 to 0.052). Similar results were obtained by using a nonparametric analysis of forced BI-RADS ratings. CONCLUSION: SM alone or in combination with tomosynthesis is comparable in performance to FFDM alone or in combination with tomosynthesis and may eliminate the need for FFDM as part of a routine clinical study.

The "laboratory" effect: comparing radiologists' performance and variability during prospective clinical and laboratory mammography interpretations.

PURPOSE: To compare radiologists' performance during interpretation of screening mammograms in the clinic with their performance when reading the same mammograms in a retrospective laboratory study. MATERIALS AND METHODS: This study was conducted under an institutional review board-approved, HIPAA-compliant protocol; the need for informed consent was waived. Nine experienced radiologists rated an enriched set of mammograms that they had personally read in the clinic (the "reader-specific" set) mixed with an enriched "common" set of mammograms that none of the participants had previously read in the clinic by using a screening Breast Imaging Reporting and Data System (BI-RADS) rating scale. The original clinical recommendations to recall the women for a diagnostic work-up, for both reader-specific and common sets, were compared with their recommendations during the retrospective experiment. The results are presented in terms of reader-specific and group-averaged sensitivity and specificity levels and the dispersion (spread) of reader-specific performance estimates. RESULTS: On average, the radiologists' performance was significantly better in the clinic than in the laboratory (P = .035). Interreader dispersion of the computed performance levels was significantly lower during the clinical interpretations (P < .01). CONCLUSION: Retrospective laboratory experiments may not represent either expected performance levels or interreader variability during clinical interpretations of the same set of mammograms in the clinical environment well.

Binary and multi-category ratings in a laboratory observer performance study: a comparison.

The authors investigated radiologists, performances during retrospective interpretation of screening mammograms when using a binary decision whether to recall a woman for additional procedures or not and compared it with their receiver operating characteristic (ROC) type performance curves using a semi-continuous rating scale. Under an Institutional Review Board approved protocol nine experienced radiologists independently rated an enriched set of 155 examinations that they had not personally read in the clinic, mixed with other enriched sets of examinations that they had individually read in the clinic, using both a screening BI-RADS rating scale (recall/not recall) and a semi-continuous ROC type rating scale (0 to 100). The vertical distance, namely the difference in sensitivity levels at the same specificity levels, between the empirical ROC curve and the binary operating point were computed for each reader. The vertical distance averaged over all readers was used to assess the proximity of the performance levels under the binary and ROC-type rating scale. There does not appear to be any systematic tendency of the readers towards a better performance when using either of the two rating approaches, namely four readers performed better using the semi-continuous rating scale, four readers performed better with the binary scale, and one reader had the point exactly on the empirical ROC curve. Only one of the nine readers had a binary "operating point" that was statistically distant from the same reader's empirical ROC curve. Reader-specific differences ranged from -0.046 to 0.128 with an average width of the corresponding 95% confidence intervals of 0.2 and p-values ranging for individual readers from 0.050 to 0.966. On average, radiologists performed similarly when using the two rating scales in that the average distance between the run in individual reader's binary operating point and their ROC curve was close to zero. The 95% confidence interval for the fixed-reader average (0.016) was (-0.0206, 0.0631) (two-sided p-value 0.35). In conclusion the authors found that in retrospective observer performance studies the use of a binary response or a semi-continuous rating scale led to consistent results in terms of performance as measured by sensitivity-specificity operating points.

Multiview-based computer-aided detection scheme for breast masses.

In this study, we developed and tested a new multiview-based computer-aided detection (CAD) scheme that aims to maintain the same case-based sensitivity level as a single-image-based scheme while substantially increasing the number of masses being detected on both ipsilateral views. An image database of 450 four-view examinations (1800 images) was assembled. In this database, 250 cases depicted malignant masses, of which 236 masses were visible on both views and 14 masses were visible only on one view. First, we detected suspected mass regions depicted on each image in the database using a single-image-based CAD. For each identified region (with detection score > or = 0.55), we then identified a matching strip of interest on the ipsilateral view based on the projected distance to the nipple along the centerline. By lowering CAD operating threshold inside the matching strip, we searched for a region located inside the strip and paired it with the original region. A multifeature-based artificial neural network scored the likelihood of the paired "matched" regions representing true-positive masses. All single (unmatched) regions except for those either with very high detection scores (> or = 0.85) or those located near the chest wall that cannot be matched on the other view were discarded. The original single-image-based CAD scheme detected 186 masses (74.4% case-based sensitivity) and 593 false-positive regions. Of the 186 identified masses, 91 were detected on two views (48.9%) and 95 were detected only on one view (51.1%). Of the false-positive detections, 54 were paired on the ipsilateral view inside the corresponding matching strips and the remaining 485 were not, which represented 539 case-based false-positive detections (0.3 per image). Applying the multiview-based CAD scheme, the same case-based sensitivity was maintained while cueing 169 of 186 masses (90.9%) on both views and at the same time reducing the case-based false-positive detection rate by 23.7% (from 539 to 411). The study demonstrated that the new multiview-based CAD scheme could substantially increase the number of masses being cued on two ipsilateral views while reducing the case-based false-positive detection rate.

Detection and classification performance levels of mammographic masses under different computer-aided detection cueing environments.

RATIONALE AND OBJECTIVES: The authors evaluated the impact of different computer-aided detection (CAD) cueing conditions on radiologists' performance levels in detecting and classifying masses depicted on mammograms. MATERIALS AND METHODS: In an observer performance study, eight radiologists interpreted 110 subtle cases six times under different display conditions to detect depicted masses and classify them as benign or malignant. Forty-five cases depicted biopsy-proven masses and 65 were negative. One mass-based cueing sensitivity of 80% and two false-positive cueing rates of 1.2 and 0.5 per image were used in this study. In one mode, radiologists first interpreted images without CAD results, followed by the display of cues and reinterpretation. In another mode, radiologists viewed CAD cues as images were presented and then interpreted images. Free-response receiver operating characteristic method was used to analyze and compare detection performance. The receiver operating characteristic method was used to evaluate classification performance. RESULTS: At these performance levels, providing cues after initial interpretation had little effect on the overall performance in detecting masses. However, in the mode with the highest false-positive cueing rate, viewing CAD cues immediately upon display of images significantly reduced average performance for both detection and classification tasks (P < .05). Viewing CAD cues during the initial display consistently resulted in fewer abnormalities being identified in noncued regions. CONCLUSION: CAD systems with low sensitivity (< or = 80% on mass-based detection) and high false-positive rate (> or = 0.5 per image) in a dataset with subtle abnormalities had little effect on radiologists' performance in the detection and classification of mammographic masses.

Computer-aided detection in mammography: an assessment of performance on current and prior images.

RATIONALE AND OBJECTIVES: The authors assessed and compared the performance of a computer-aided detection (CAD) scheme for the detection of masses and microcalcification clusters on a set of images collected from two consecutive ("current" and "prior") mammographic examinations. MATERIALS AND METHODS: A previously developed CAD scheme was used to assess two consecutive screening mammograms from 200 cases in which the current mammogram showed a mass or cluster of microcalcifications that resulted in breast biopsy. The latest prior examinations had been initially interpreted as negative or definitely benign findings (Breast Imaging Reporting and Data System rating, 1 or 2). The study involved images of 400 examinations acquired in 200 patients. Radiologists identified 172 masses and 128 clusters of microcalcifications on the current images. The performance of the CAD scheme was analyzed and compared for the current and latest prior images. RESULTS: There were significant differences (P < .01) between current and prior images in many feature values. The performance of the CAD scheme was significantly lower for prior than for current images (P < .01). At 0.5 and 0.2 false-positive mass and cluster cues per image, the scheme detected 78 malignant masses (78%) and 63 malignant clusters (80%) on current images. Only 42% of malignant cases were detected on prior images, including 40 masses (40%) and 36 microcalcification clusters (46%). CONCLUSION: CAD schemes can detect a substantial fraction of masses and microcalcification clusters depicted on prior images. To improve performance with prior images, the scheme may have to be adaptively reoptimized with increasingly more subtle abnormalities.

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.

Agreement of the order of overall performance levels under different reading paradigms.

RATIONALE AND OBJECTIVES: To investigate consistency of the orders of performance levels when interpreting mammograms under three different reading paradigms. MATERIALS AND METHODS: We performed a retrospective observer study in which nine experienced radiologists rated an enriched set of mammography examinations that they personally had read in the clinic ("individualized") mixed with a set that none of them had read in the clinic ("common set"). Examinations were interpreted under three different reading paradigms: binary using screening Breast Imaging Reporting and Data System (BI-RADS), receiver-operating characteristic (ROC), and free-response ROC (FROC). The performance in discriminating between cancer and noncancer findings under each of the paradigms was summarized using Youden's index/2+0.5 (Binary), nonparameteric area under the ROC curve (AUC), and an overall FROC index (JAFROC-2). Pearson correlation coefficients were then computed to assess consistency in the ordering of observers' performance levels. Statistical significance of the computed correlation coefficients was assessed using bootstrap confidence intervals obtained by resampling sets of examination-specific observations. RESULTS: All but one of the computed pair-wise correlation coefficients were larger than 0.66 and were significantly different from zero. The correlation between the overall performance measures under the Binary and ROC paradigms was the lowest (0.43) and was not significantly different from zero (95% confidence interval -0.078 to 0.733). CONCLUSION: The use of different evaluation paradigms in the laboratory tends to lead to consistent ordering of the overall performance levels of observers. However, one should recognize that conceptually similar performance indexes resulting from different paradigms often measure different performance characteristics and thus disagreements are not only possible but frequently quite natural.

A multisite telemammography system for remote management of screening mammography: an assessment of technical, operational, and clinical issues.

OBJECTIVE: This paper describes a high-quality, multisite telemammography system to enable "almost real-time" remote patient management while the patient remains in the clinic. One goal is to reduce the number of women who would physically need to return to the clinic for additional imaging procedures (termed "recall") to supplement "routine" imaging of screening mammography. MATERIALS AND METHODS: Mammography films from current and prior (when available) examinations are digitized at three remote sites and transmitted along with other pertinent information across low-level communication systems to the central site. Images are automatically cropped, wavelet compressed, and encrypted prior to transmission to the central site. At the central site, radiologists review and rate examinations on a high-resolution workstation that displays the images, computer-assisted detection results, and the technologist's communication. Intersite communication is provided instantly via a messaging "chat" window. RESULTS: The technologists recommended additional procedures at 2.7 times the actual clinical recall rate for the same cases. Using the telemammography system during a series of "off-line" clinically simulated studies, radiologists recommended additional procedures at 1.3 times the actual clinical recall rate. Percent agreement and kappa between the study and actual clinical interpretations were 66.1% and 0.315, respectively. For every physical recall potentially avoided using the telemammography system, approximately one presumed "unnecessary" imaging procedure was recommended. CONCLUSION: Remote patient management can reduce the number of women recalled by as much as 50% without performing an unreasonable number of presumed "unnecessary" procedures.

Trends in recall, biopsy, and positive biopsy rates for screening mammography in an academic practice.

PURPOSE: To retrospectively evaluate whether recall, biopsy, and positive biopsy rates for a group of radiologists who met requirements of Mammography Quality Standards Act of 1992 (MQSA) demonstrated any change over time during a 27-month period (nine consecutive calendar quarters). MATERIALS AND METHODS: Institutional review board approved study protocol, and informed consent was waived. All screening mammograms that had been interpreted by MQSA-qualified radiologists between January 1, 2001, and March 31, 2003, were reviewed. Group recall rates, biopsy rates, and detected cancer rates for nine calendar quarters were computed and attributed to performance date of original screening mammogram. Type of biopsy performed was classified as follows: stereotactic vacuum-assisted biopsy, ultrasonography (US)-guided core biopsy, US-guided fine-needle aspiration biopsy, surgical excision, and multiple biopsies. chi(2) Test for trend (two sided) and linear regression were used to assess trends over time for recall and biopsy rates, biopsy rates according to type of biopsy performed, and percentage of biopsy results positive for cancer. RESULTS: Group recall rate did not show a statistically significant trend during period studied (P = .59). Biopsy rates increased significantly from 13.02 to 20.12 per 1000 screening examinations (P < .001). A corresponding substantial decrease was seen in percentage of biopsies in which malignancy was found, although this trend was not statistically significant (P = .24). A significant increase (from 4.72 to 9.88 per 1000 screening examinations) was found in rate of stereotactic vacuum-assisted 11-gauge core biopsies performed (P < .001). CONCLUSION: Observed increase in biopsy rates reinforces the need to carefully select patients for biopsy to achieve efficient, efficacious, and cost-effective programs for early detection of breast cancers.

Changes in breast cancer detection and mammography recall rates after the introduction of a computer-aided detection system.

BACKGROUND: Computer-aided mammography is rapidly gaining clinical acceptance, but few data demonstrate its actual benefit in the clinical environment. We assessed changes in mammography recall and cancer detection rates after the introduction of a computer-aided detection system into a clinical radiology practice in an academic setting. METHODS: We used verified practice- and outcome-related databases to compute recall rates and cancer detection rates for 24 Mammography Quality Standards Act-certified academic radiologists in our practice who interpreted 115,571 screening mammograms with (n = 59,139) or without (n = 56,432) the use of a computer-aided detection system. All statistical tests were two-sided. RESULTS: For the entire group of 24 radiologists, recall rates were similar for mammograms interpreted without and with computer-aided detection (11.39% versus 11.40%; percent difference = 0.09, 95% confidence interval [CI] = -11 to 11; P =.96) as were the breast cancer detection rates for mammograms interpreted without and with computer-aided detection (3.49% versus 3.55% per 1000 screening examinations; percent difference = 1.7, 95% CI = -11 to 19; P =.68). For the seven high-volume radiologists (i.e., those who interpreted more than 8000 screening mammograms each over a 3-year period), the recall rates were similar for mammograms interpreted without and with computer-aided detection (11.62% versus 11.05%; percent difference = -4.9, 95% CI = -21 to 4; P =.16), as were the breast cancer detection rates for mammograms interpreted without and with computer-aided detection (3.61% versus 3.49% per 1000 screening examinations; percent difference = -3.2, 95% CI = -15 to 9; P =.54). CONCLUSION: The introduction of computer-aided detection into this practice was not associated with statistically significant changes in recall and breast cancer detection rates, both for the entire group of radiologists and for the subset of radiologists who interpreted high volumes of mammograms.

Recall and detection rates in screening mammography.

BACKGROUND: The authors investigated the correlation between recall and detection rates in a group of 10 radiologists who had read a high volume of screening mammograms in an academic institution. METHODS: Practice-related and outcome-related databases of verified cases were used to compute recall rates and tumor detection rates for a group of 10 Mammography Quality Standard Act (MQSA)-certified radiologists who interpreted a total of 98,668 screening mammograms during the years 2000, 2001, and 2002. The relation between recall and detection rates for these individuals was investigated using parametric Pearson (r) and nonparametric Spearman (rho) correlation coefficients. The effect of the volume of mammograms interpreted by individual radiologists was assessed using partial correlations controlling for total reading volumes. RESULTS: A wide variability of recall rates (range, 7.7-17.2%) and detection rates (range, 2.6-5.4 per 1000 mammograms) was observed in the current study. A statistically significant correlation (P < 0.05) between recall and detection rates was observed in this group of 10 experienced radiologists. The results remained significant (P < 0.05) after accounting for the volume of mammograms interpreted by each radiologist. CONCLUSIONS: Optimal performance in screening mammography should be evaluated quantitatively. The general pressure to reduce recall rates through "practice guidelines" to below a fixed level for all radiologists should be assessed carefully.