Prospective Study of Supplemental Screening With Contrast-Enhanced Mammography in Women With Elevated Risk of Breast Cancer: Results of the Prevalence Round.

PURPOSE: Contrast-enhanced mammography (CEM) and magnetic resonance imaging (MRI) have shown similar diagnostic performance in detection of breast cancer. Limited CEM data are available for high-risk breast cancer screening. The purpose of the study was to prospectively investigate the efficacy of supplemental screening CEM in elevated risk patients. MATERIALS AND METHODS: A prospective, single-institution, institutional review board-approved observational study was conducted in asymptomatic elevated risk women age 35 years or older who had a negative conventional two-dimensional digital breast tomosynthesis screening mammography (MG) and no additional supplemental screening within the prior 12 months. RESULTS: Four hundred sixty women were enrolled from February 2019 to April 2021. The median age was 56.8 (range, 35.0-79.2) years; 408 of 460 (88.7%) were mammographically dense. Biopsy revealed benign changes in 22 women (22/37, 59%), high-risk lesions in four women (4/37, 11%), and breast cancer in 11 women (11/37, 30%). Fourteen cancers (10 invasive, tumor size range 4-15 mm, median 9 mm) were diagnosed in 11 women. The overall supplemental cancer detection rate was 23.9 per 1,000 patients, 95% CI (12.0 to 42.4). All cancers were grade 1 or 2, ER+ ERBB2-, and node negative. CEM imaging screening offered high specificity (0.875 [95% CI, 0.844 to 0.906]), high NPV (0.998 [95% CI, 0.993 to 1.000), moderate PPV1 (0.164 [95% CI, 0.076 to 0.253), moderate PPV3 (0.275 [95% CI, 0.137 to 0.413]), and high sensitivity (0.917 [95% CI, 0.760 to 1.000]). At least 1 year of imaging follow-up was available on all patients, and one interval cancer was detected on breast MRI 4 months after negative screening CEM. CONCLUSION: A pilot trial demonstrates a supplemental cancer detection rate of 23.9 per 1,000 in women at an elevated risk for breast cancer. Larger, multi-institutional, multiyear CEM trials in patients at elevated risk are needed for validation.

Contrast Enhanced Mammography in Routine Clinical Practice: Frequency and Malignancy Rates of Enhancing Otherwise Occult Findings.

BACKGROUND: In routine clinical practice, contrast-enhanced mammography (CEM) examinations identify enhancing findings seen only on subtraction images that have no low-energy mammographic or sonographic correlate. The purpose of this study is to report the frequency and malignancy rates of enhancing findings seen only on subtraction images in a tertiary care breast imaging practice. MATERIALS AND METHODS: Consecutive review of CEM exams from December 2015 to May 2020. Chi square tests were used to determine associations between cancer diagnosis and clinical characteristics of enhancing findings seen only on subtraction images, P < .05 indicating a statistically significant difference. RESULTS: Four percent (100/2464) of CEM examinations identified 108 enhancing findings seen only on subtraction images. Twenty of those CEM enhancing findings were directly managed as a multifocal disease. Of those further evaluated with MR, 23% (19/78) with associated MR correlates were treated surgically as presumed multicentric or multifocal disease following multidisciplinary review. The remaining 76% (59/78) of enhancing findings were seen only on subtraction images, these included: 20% (12/59) and downgraded to benign on MR 80% (47/59) with suspicious findings which underwent MR vacuum assisted breast biopsy yielding: 26% (12/47) malignancy, 9% (4/47) high risk, and 66% (31/47) benign diagnoses. CONCLUSION: Enhancing findings seen on subtraction only CEM images are seen in 4% of cases in clinical practice. MR correlation can help characterize CEM findings to: (1) avoid unnecessary biopsy for benign findings, and (2) guide tissue sampling or empiric surgical planning for suspicious findings.

The Dense Breast Clinic: Initial Experience of a Patient-Centered Breast Imaging Clinic.

OBJECTIVE: Establish a radiologist-run consultation clinic to review breast density and supplemental screening exams (SSEs) directly with patients in response to breast density reporting laws. METHODS: Breast radiologists opened and staffed a clinic for formal patient consultations regarding breast density and SSEs. An IRB-approved questionnaire assessed patient knowledge of breast density, SSEs, and encounter satisfaction. Comparative statistical analyses were performed on knowledge-based questions. RESULTS: From February 2019 to February 2021, 294 reimbursable consultations were performed with 215 patients completing pre- and post-consultation questionnaires (survey response rate, 73%). Median patient age was 58 years (range, 34-86 years) and 9% (19/210) had a personal history of breast cancer. An increase in patient knowledge of breast density and SSEs was observed as follows: breast density categories (9% correct pre-consultation (20/215), 86% correct post-consultation (185/215), P < 0.001), dense breast effects on cancer risk (39% correct pre-consultation (83/215), 84% post-consultation (180/215)), mammogram sensitivity (90% correct pre-consultation (193/215), 94% post-consultation (201/215)), and increased cancer detection with SSEs (82% correct pre-consultation (177/215), 95% post-consultation (205/215)) (P < 0.001). Post-consultation, 96% (200/209) were satisfied with the usefulness of information, 89% (186/209) strongly agreed they had sufficient knowledge of SSEs, and 81% (167/205) agreed they would like future opportunities to meet with a breast radiologist. CONCLUSION: A consultation clinic staffed by breast radiologists focused on breast density and supplemental breast cancer screening can provide personalized patient counseling, engage patients in shared decision making, assist referring clinicians, and support high quality patient-centered care.

Contrast-Enhanced Mammography for Newly Diagnosed Breast Cancer in Women With Breast Augmentation: Preliminary Findings.

In 17 women with newly diagnosed breast cancer who underwent contrast-enhanced mammography (CEM) and MRI, both modalities were found to be concordant for the index cancer. In six of the 17 women, CEM showed an additional lesion that was confirmed by MRI. Of these six additional lesions, three were multifocal, one was multicentric, and two were contralateral; two of the six were malignant. MRI did not identify any additional cancers that were not identified on CEM. CEM may have a role in women with breast augmentation and either a contraindication or limited access to MRI.

Radiologists Make More Errors Interpreting Off-Hours Body CT Studies during Overnight Assignments as Compared with Daytime Assignments.

Background There is increasing research attention on the impact of overnight work on radiologist performance. Prior studies on overnight imaging interpretive errors have focused on radiology residents, not on the relative performance of board-eligible or board-certified radiologists at night compared with during the day. Purpose To analyze the rate of clinically important interpretation errors on CT examinations of the abdomen, pelvis, or both ("body CT studies") committed by radiology fellows working off-hours based on day or night assignment. Materials and Methods Between July 2014 and June 2018, attending physicians at one tertiary care institution reviewed all body CT studies independently interpreted off-hours by radiologists in an academic fellowship within 10 hours of initial interpretation. Discrepancies affecting acute or follow-up clinical care were classified as errors. In this retrospective study, the error rate for studies interpreted during the day (between 7:00 am and 5:59 pm) was compared with that of studies interpreted at night (between 6:00 pm and 6:59 am). Error rate in the first half of day and night assignments was compared with error rate in the latter half. Statistical analyses used χ2 tests and general estimating equations; significance was defined as P < .05. Results There were 10 090 body CT studies interpreted by 32 radiologists. Forty-four of 2195 daytime studies (2.0%) had errors compared with 240 of 7895 nighttime studies (3.0%; P = .02). Twenty-two of 32 (69%) radiologists had higher error rates for night cases (P = .03). There were more errors in the last half of a night assignment (125 of 3358, 3.7%; P = .002) compared with the first half (115 of 4537, 2.5%). Conclusion On the basis of a subspecialty review, clinically important off-hours body CT interpretation errors occurred more frequently overnight and more frequently in the latter half of assignments, with more radiologists having worse error rates at night compared with the day. © RSNA, 2020 See also the editorial by Bruno in this issue.

Initial Experience of Tomosynthesis-Guided Vacuum-Assisted Biopsies of Tomosynthesis-Detected (2D Mammography and Ultrasound Occult) Architectural Distortions.

OBJECTIVE: As experience and aptitude in digital breast tomosynthesis (DBT) have increased, radiologists are seeing more areas of architectural distortion (AD) on DBT images compared with standard 2D mammograms. The purpose of this study is to report our experience using tomosynthesis-guided vacuum-assisted biopsies (VABs) for ADs that were occult at 2D mammography and ultrasound and to analyze the positive predictive value for malignancy. MATERIALS AND METHODS: We performed a retrospective review of 34 DBT-detected ADs that were occult at mammography and ultrasound. RESULTS: We found a positive predictive value of 26% (nine malignancies in 34 lesions). Eight of the malignancies were invasive and one was ductal carcinoma in situ. The invasive cancers were grade 1 (4/8; 50%), grade 2 (2/8; 25%), or grade 3 (1/8; 13%); information about one invasive cancer was not available. The mean size of the invasive cancers at pathologic examination was 7.5 mm (range, 6-30 mm). CONCLUSION: Tomosynthesis-guided VAB is a feasible method to sample ADs that are occult at 2D mammography and ultrasound. Tomosynthesis-guided VAB is a minimally invasive method that detected a significant number of carcinomas, most of which were grade 1 cancers. Further studies are needed.

Operative outcomes of conventional specimen radiography versus in-operating room specimen radiography in radioactive seed-localized segmental mastectomies.

INTRODUCTION: In-operating room specimen radiography (ORSR) has not been studied among women undergoing radioactive seed localization (RSL) for breast cancer surgery and had the potential to decrease operative time and perhaps improve intraoperative margin management. METHODS: One hundred consecutive RSL segmental mastectomies among 98 patients using ORSR were compared to 100 consecutive segmental mastectomies among 98 patients utilizing conventional radiography (CSR) prior to the initiation of ORSR from December 2013 to January 2015 after radioactive seed localization. Final pathologic margins were considered to be 10 mm for all cases of no residual disease after biopsy or neoadjuvant therapy, but such patients were excluded from analyses involving tumor size. All patients' specimens were subjected to intraoperative pathologic consultation in addition to ORSR or CSR. RESULTS: The median age of the cohort was 65 years (range 36-97), and the median tumor size was 1 cm. There were no differences between the ORSR and CSR groups in age, tumor size, percentage of cases with only DCIS, and percentage of cases with microcalcifications. The ORSR group had a statistically significant lower BMI. Mean operative time from cut-to-close was not significantly different (ORSR 77 min, SD 24.8 vs CSR 76 min, SD 24.8, p = 0.75). There was no statistical difference in mean closest final pathologic margin (4.99 mm, SD 3.3 vs 4.88 mm, SD 3.5, p = 0.9). The percentage undergoing intraoperative margin re-excision (ORSR 40%, CR 47%, p = 0.31) and the mean total number of margins excised intraoperatively (ORSR 0.9, CR 1.0 p = 0.65) were similar. The rate of any margin <2 mm was 14% vs 12% for ORSR and CR, respectively (p = 0.64). The mean specimen volume for ORSR was 76cm3 (SD 101.8) vs 90cm3 (SD 61.2) for CSR; this difference was not statistically significant (p = 0.25). The mean ratio of segmental mastectomy volume to maximum tumor diameter was less for ORSR (82.7cm2 vs 139.4cm2, p = 0.014). CONCLUSION: ORSR for RSL breast surgery, in the setting of routine intraoperative pathology consultation, does not significantly impact operative time, the rate or number of additional intraoperative margins excised, the number of reoperations for margins, or the width of final pathological margins. ORSR was associated with a decrease in the volume of segmental mastectomies relative to the tumor diameter.

The Future of Contrast-Enhanced Mammography.

OBJECTIVE: The purpose of this article is to discuss facilitators of and barriers to future implementation of contrast-enhanced mammography (CEM) in the United States. CONCLUSION: CEM provides low-energy 2D mammographic images analogous to digital mammography and contrast-enhanced recombined images that allow assessment of neovascularity similar to that offered by MRI. The utilization of CEM in the United States is currently low but could increase rapidly given the many potential indications for its clinical use.

Variability of Postsurgical Imaging Surveillance of Breast Cancer Patients: A Nationwide Survey Study.

OBJECTIVE: Because of observed clinical variance and the discretion of referring physicians and radiologists in patient follow-up, the purpose of this study was to conduct a survey to explore whether broad discrepancy exists in imaging protocols used for postsurgical surveillance. SUBJECTS AND METHODS: An online survey was created to assess radiologists' use of diagnostic versus screening mammography for women with a personal history of breast cancer and determine whether the choice of protocol was associated with practice characteristics (setting, region, and reader type). RESULTS: Of 8170 surveys sent, 849 (10%) completed responses were returned. Seventy-nine percent of respondents recommended initial diagnostic mammography after lumpectomy (65% at 6 months, 14% at 12 months); 49% recommended diagnostic surveillance for up to 2 years before a return to screening mammography; and 33% continued diagnostic surveillance for 2-5 years before returning to screening. For imaging after mastectomy, 57% of respondents recommended diagnostic mammography of the unaffected breast. Among the 57%, however, 37% recommended diagnostic screening for only the first postmastectomy follow-up evaluation, and the other 20% permanently designated patients for diagnostic mammography after mastectomy. CONCLUSION: The optimal surveillance mammography regimen must be better defined. This preliminary study showed variability in diagnostic versus screening surveillance mammography for women with a history of breast cancer. Future studies should evaluate why these variations occur and how to standardize recommendations to tailor personalized imaging.

Clinical utility of contrast-enhanced spectral mammography as an adjunct for tomosynthesis-detected architectural distortion.

OBJECTIVE: Supplement tomosynthesis-detected architectural distortions (AD) with CESM to better characterize malignant vs benign lesions. METHODS: Retrospective review CESM prior to biopsied AD. Pathology: benign, radial scar, or malignant. RESULTS: 49 lesions (45 patients). 29 invasive cancers, 1 DCIS (range, 0.4-4.7cm); 9 radial scars; 10 benign. 37 (75.5%) ADs had associated enhancement. PPV 78.4% (29/37), sensitivity 96.7% (29/30); specificity, 57.9% (11/19); NPV, 91.7% (11/12). False-positive rate 21.6% (8/37); false-negative rate, 8.3% (1/12). Accuracy 81.6% (40/49). CONCLUSIONS: High sensitivity and NPV of CESM in patients with AD is promising as an adjunct tool in diagnosing malignancy and avoiding unnecessary biopsy, respectively.

Contrast-enhanced Digital Mammography: A Single-Institution Experience of the First 208 Cases.

Contrast-enhanced digital mammography (CEDM) is the only imaging modality that provides both (a) a high-resolution, low-energy image comparable to that of digital mammography and (b) a contrast-enhanced image similar to that of magnetic resonance imaging. We report the initial 208 CEDM examinations performed for various clinical indications and provide illustrative case examples. Given its success in recent studies and our experience of CEDM primarily as a diagnostic adjunct, CEDM can potentially improve breast cancer detection by combining the low-cost conclusions of screening mammography with the high sensitivity of magnetic resonance imaging.

Contrast-Enhanced Digital Mammography in the Surgical Management of Breast Cancer.

BACKGROUND: Contrast-enhanced digital mammography (CEDM) is a new breast imaging technique. The role of CEDM in the surgical management of breast cancer has not yet been characterized. METHODS: A retrospective review of prospective breast surgery and breast imaging databases for patients who underwent CEDM and had breast cancer surgery. RESULTS: A total of 351 patients had CEDM; 128 had malignant lesions, and 101 of these underwent surgery with 105 malignancies identified. The mean age was 62 years (range 25-85 years). The histology was 65 % invasive ductal carcinoma, 16 % invasive lobular carcinoma, 11 % ductal carcinoma-in situ, 3 % mixed invasive ductal carcinoma/invasive lobular carcinoma, and 5 % other histologies. After excluding two lesions that had been removed before the examination, CEDM identified 98 % (n = 101/103) of the index lesions. The two lesions not identified were Paget disease only and a parasternal lesion too medial to include in the field of view. CEDM led to additional biopsies in 12 % (n = 12) of patients. Of these, 67 % (n = 8) proved to be invasive carcinoma and 33 % (n = 4) were benign. CEDM changed surgical management in 20 % (n = 20) of cancer patients with a 4 % (n = 4) rate of conversion to mastectomy. CONCLUSIONS: Among patients undergoing surgical therapy for breast cancer, CEDM was highly sensitive, had size measurements that correlated well with histologic size, and produced a relatively low rate of false-positive additional biopsy findings. CEDM appears to be promising as an alternative to magnetic resonance imaging in the surgical planning of these patients.

Utilization of Multiple I-125 Radioactive Seeds in the Same Breast is Safe and Feasible: A Multi-institutional Experience.

OBJECTIVE: Radioactive seed localization has been shown to be a reliable and safe alternative to wire localization in breast surgery, but little is known about the use of multiple localization seeds. This study evaluated the utilization of multiple seeds in the same breast. METHODS: All patients who underwent localization of breast lesions using multiple I-125 seeds at three Mayo Clinic sites between January 2003 and June 2014 were included. RESULTS: A total of 461 operations were performed during an 11.5-year study period. The indications for multiple seed placement in the same breast included multiple lesions (n = 258), bracketing (n = 110), multiple lesions and bracketing (n = 67), and a second inserted for more precise localization (n = 26). Among patients with bracketing seeds, the mean distance between seeds was 45 (range 8-110) mm. Removal of the targeted lesion was successful in all cases; 96% of bracketed lesions were removed as a single specimen, and a 98% retrieval rate within the first specimen was obtained. In total 108 of 382 (28%) patients had close or positive margin resulting in a second procedure and 60 of 177 (34%) patients with bracketing procedures underwent reexcision of positive margins or culminated in a mastectomy. Routine intraoperative frozen section analysis was associated with a lower reoperation rate compared with a selective approach to intraoperative margin assessment. CONCLUSIONS: The use of multiple radioactive seeds for localizing multiple lesions in the same breast or bracketing lesions is feasible and safe. Because of the extent of disease, a substantial percentage of these patients require margin reexcision or conversion to mastectomy.

Validation study of a modern treatment algorithm for nipple discharge.

BACKGROUND: Nipple discharge occurs in 2% to 5% of women. We evaluated the effectiveness of a previously proposed treatment algorithm for these patients. METHODS: Patients with pathologic nipple discharge and a negative mammogram and subareolar ultrasound were offered follow-up from 2005 to 2011 according to the algorithm. RESULTS: A total of 192 patients, mean age 56 years, were studied. Risk of carcinoma among the entire cohort was 5%. Breast surgeon was consulted for 142 (74%) patients: 48 (34%) underwent initial subareolar excision and 94 (66%) were clinically followed. The rate of carcinoma was 17% (8/48) after initial subareolar excision, 0% (0/13) for those without imaging abnormalities, 23% (8/35) with imaging abnormalities, and 1% (1/94) with clinical follow-up. Of patients who underwent follow-up, 21% (n = 20) underwent subareolar excision because of imaging abnormality (n = 1, 1%) or persistent discharge (n = 19, 20%). Most patients had ductal carcinoma in situ (n = 5, 56%). CONCLUSIONS: Patients with nipple discharge can be prospectively identified based on radiographic findings and clinical examination for safe clinical follow-up. Most will have resolution avoiding a surgical procedure.

Clinical and self breast examination remain important in the era of modern screening.

BACKGROUND: Breast cancer screening recommendations are in flux. We reviewed the methods of detecting newly diagnosed breast neoplasms at our institution. METHODS: A retrospective review of patients stratified by age was performed to compare mammography with self- (SBE) and clinical (CBE) breast examination methods of cancer detection from 2005 to 2009. RESULTS: We identified 782 patients. Patients aged <50 years were more likely to present with palpable disease (P < 0.001). Overall, 75% of patients had a mammogram within 24 months. There was a higher incidence of Tis tumors and lower incidence of T1 tumors if patients had mammography performed within 12 months versus 13-24 months (P < 0.01); tumor size, hormonal status, and lymph node (LN) status were comparable between these two groups. Patients diagnosed by SBE/CBE who had mammography performed within 12 months versus 13-24 months did not differ statistically according to tumor characteristics. In the screened cohort (mammography within 24 months), the majority of patients (64%) were diagnosed by mammography. Cancers detected by SBE/CBE were larger tumors (2.4 vs. 1.3 cm), higher grade, more frequently ER- (29 vs. 16%), triple-negative (21 vs. 10%), and lymph node-positive (39 vs. 18%; all P ≤ 0.01). There were no statistically significant differences in tumor size, T stage, or hormonal status in patients who had analog versus digital mammography. CONCLUSIONS: Whereas the majority of patients had image-detected breast cancer, a significant number of image-screened patients presented with palpable disease, which were more aggressive cancers. Until imaging techniques are refined, SBE and CBE remain important for breast cancer diagnosis.

Use of preoperative magnetic resonance imaging for invasive lobular cancer: good, better, but maybe not the best?

BACKGROUND: Invasive lobular cancer (ILC) of the breast is difficult to diagnose clinically and radiologically. It is hoped that preoperative magnetic resonance imaging (MRI) can improve evaluation of extent of disease. METHODS: Patients diagnosed with ILC at a single institution from 2001 to 2008 who underwent clinical breast examination (CBE), mammography, ultrasound, and MRI were studied retrospectively. Concordance between tumor size on imaging/CBE and pathologic size was defined as size within ± 0.5 cm. Pearson correlation coefficients (R) were calculated for each modality. Local recurrence and re-excision rates were compared with those patients with ILC who did not undergo preoperative MRI. RESULTS: Seventy patients with ILC had all imaging modalities, including CBE, performed preoperatively. The sensitivity for detection of ILC by MRI was 99%. MRI-based tumor size was concordant with pathologic tumor size in 56% of tumors. MRI overestimated tumor size by >0.5 cm in 31% of tumors. Correlation of tumor size on imaging with final pathology was better for MRI (R = 0.75) than for mammography (R = 0.65), CBE (R = 0.63), or ultrasound (R = 0.45, all P < 0.01). Preoperative MRI was associated with lower reoperation rates for close/positive margins (P > 0.05). CONCLUSIONS: For ILC, MRI has better sensitivity of detection and correlation with tumor size at pathology than CBE, mammography, or ultrasound. However, 31% of cases are overestimated by MRI, and correlation remains only at 0.75. The select use of MRI for preoperative estimation of tumor size in ILC is supported by our data, but the need for improvement and refinement of imaging remains.