Excluding whole grain-containing foods from the Nova ultraprocessed food category: a cross-sectional analysis of the impact on associations with cardiometabolic risk measures.

BACKGROUND: Whole grain (WG) consumption is linked with a reduced risk of chronic disease. However, the recommendations of the Nova classification system tend to contradict this evidence as high WG-containing foods, such as bread and cereals, are considered ultraprocessed, and intake is discouraged. OBJECTIVES: This study aimed to explore associations of cardiometabolic risk measures with ultraprocessed food (UPF) intake as classified by Nova compared with when foods with ≥25% and ≥50% WG are removed from the Nova UPF category. METHODS: A cross-sectional analysis of the 2015-18 National Health and Nutrition Examination Survey. Nova was used to identify UPFs, and the WG Initiative's definition of a WG food and front-of-pack labeling requirements was used to identify high WG foods. Regression models were used to explore impacts on the association of UPF intake (quintiles) and cardiometabolic risk measures when high WG foods were excluded from the Nova UPF category. RESULTS: Participants in the highest quintile of UPF intake had significantly higher weight [83.6 kg (0.8)], BMI (in kg/m2) [30.6 (0.3)], waist circumference [103.1 cm (0.6)], and weight-to-height ratio [0.63 (0.003)] compared to those in the lowest quintile (P < 0.0001 for all). The same was found when foods with ≥25% and ≥50% WG were removed. Positive associations for C-reactive protein were found when ≥25% and ≥50% WG-containing foods were removed only [2.32 mg/L (0.1), P = 0.0209; 2.37 mg/L (0.1), P = 0.0179, respectively]. Participants in the highest quintile had significantly lower total cholesterol after adjustment when foods with ≥50% WG were removed [4.98 mmol/L (0.04), P = 0.0292]. Adjusted R2 values remained relatively unchanged across each approach for all outcomes. CONCLUSIONS: Foods high in WG may not significantly contribute to the deleterious associations previously observed between UPF intake and cardiometabolic risk factors. Consideration of their contribution to healthful dietary patterns and diet quality in the United States population should be made prior to the endorsement of Nova.

The role of digital mammographic surveillance for detection of asymptomatic recurrence in autologous flap reconstructions.

OBJECTIVE: To evaluate the utility of digital mammography in detecting asymptomatic malignancy in autologous flap reconstructions after mastectomy. METHODS: A retrospective database review identified all mammograms performed on asymptomatic patients with flap reconstructions over a 9-year period (1/1/2009 to 12/31/2017). A negative examination was defined as BI-RADS 1 or 2 and a positive examination was defined as BI-RADS 0, 4, or 5 assigned to the mastectomy side. Malignant outcomes were determined by pathology results. Interval cancers, or false negatives, were defined as locoregional malignant diagnosis within one year of a negative mammogram. Sensitivity, specificity, predictive values, abnormal interpretation rate, and cancer detection rate were calculated. RESULTS: 626 mammograms of asymptomatic flap reconstructions were performed in 183 patients. The most common flap type was TRAM (83.5 %, 523/626) and DIEP (13.4 %, 84/626). Most exams (98.2 %, 615/626) were negative, assessed as BI-RADS 1 or 2, with no interval cancers at follow-up. Eleven exams (1.8 %, 11/626) were positive, assessed as BI-RADS 0, 4, or 5. After diagnostic work-up of all BI-RADS 0 exams, 9 cases had a final recommendation for biopsy of which 3 were malignant. Mammography yielded a cancer detection rate of 0.5 % (3/626), abnormal interpretation rate of 1.8 % (11/626), NPV of 100 % (615/615), overall PPV of 27.3 % (3/11), PPV2 (positive predictive value of a biopsy recommendation) of 33.3 % (3/9), sensitivity of 100 % (3/3), and specificity of 98.7 % (615/623). CONCLUSION: Digital mammography of asymptomatic autologous flap reconstructions after mastectomy demonstrated high sensitivity and low abnormal interpretation rate. Cancer detection rate was comparable to current national benchmarks for mammographic screening in the general U.S. population without mastectomy.

Effect of Longitudinal Variation in Tumor Volume Estimation for MRI-guided Personalization of Breast Cancer Neoadjuvant Treatment.

Purpose To investigate the impact of longitudinal variation in functional tumor volume (FTV) underestimation and overestimation in predicting pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC). Materials and Methods Women with breast cancer who were enrolled in the prospective I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2) from May 2010 to November 2016 were eligible for this retrospective analysis. Participants underwent four MRI examinations during NAC treatment. FTV was calculated based on automated segmentation. Baseline FTV before treatment (FTV0) and the percentage of FTV change at early treatment and inter-regimen time points relative to baseline (∆FTV1 and ∆FTV2, respectively) were classified into high-standard or standard groups based on visual assessment of FTV under- and overestimation. Logistic regression models predicting pCR using single predictors (FTV0, ∆FTV1, and ∆FTV2) and multiple predictors (all three) were developed using bootstrap resampling with out-of-sample data evaluation with the area under the receiver operating characteristic curve (AUC) independently in each group. Results This study included 432 women (mean age, 49.0 years ± 10.6 [SD]). In the FTV0 model, the high-standard and standard groups showed similar AUCs (0.61 vs 0.62). The high-standard group had a higher estimated AUC compared with the standard group in the ∆FTV1 (0.74 vs 0.63), ∆FTV2 (0.79 vs 0.62), and multiple predictor models (0.85 vs 0.64), with a statistically significant difference for the latter two models (P = .03 and P = .01, respectively). Conclusion The findings in this study suggest that longitudinal variation in FTV estimation needs to be considered when using early FTV change as an MRI-based criterion for breast cancer treatment personalization. Keywords: Breast, Cancer, Dynamic Contrast-enhanced, MRI, Tumor Response ClinicalTrials.gov registration no. NCT01042379 Supplemental material is available for this article. © RSNA, 2023 See also the commentary by Ram in this issue.

Safety and efficacy of HSP90 inhibitor ganetespib for neoadjuvant treatment of stage II/III breast cancer.

HSP90 inhibitors destabilize oncoproteins associated with cell cycle, angiogenesis, RAS-MAPK activity, histone modification, kinases and growth factors. We evaluated the HSP90-inhibitor ganetespib in combination with standard chemotherapy in patients with high-risk early-stage breast cancer. I-SPY2 is a multicenter, phase II adaptively randomized neoadjuvant (NAC) clinical trial enrolling patients with stage II-III breast cancer with tumors 2.5 cm or larger on the basis of hormone receptors (HR), HER2 and Mammaprint status. Multiple novel investigational agents plus standard chemotherapy are evaluated in parallel for the primary endpoint of pathologic complete response (pCR). Patients with HER2-negative breast cancer were eligible for randomization to ganetespib from October 2014 to October 2015. Of 233 women included in the final analysis, 140 were randomized to the standard NAC control; 93 were randomized to receive 150 mg/m2 ganetespib every 3 weeks with weekly paclitaxel over 12 weeks, followed by AC. Arms were balanced for hormone receptor status (51-52% HR-positive). Ganetespib did not graduate in any of the biomarker signatures studied before reaching maximum enrollment. Final estimated pCR rates were 26% vs. 18% HER2-negative, 38% vs. 22% HR-negative/HER2-negative, and 15% vs. 14% HR-positive/HER2-negative for ganetespib vs control, respectively. The predicted probability of success in phase 3 testing was 47% HER2-negative, 72% HR-negative/HER2-negative, and 19% HR-positive/HER2-negative. Ganetespib added to standard therapy is unlikely to yield substantially higher pCR rates in HER2-negative breast cancer compared to standard NAC, and neither HSP90 pathway nor replicative stress expression markers predicted response. HSP90 inhibitors remain of limited clinical interest in breast cancer, potentially in other clinical settings such as HER2-positive disease or in combination with anti-PD1 neoadjuvant chemotherapy in triple negative breast cancer.Trial registration: www.clinicaltrials.gov/ct2/show/NCT01042379.

Diffusion-Weighted MRI for Predicting Pathologic Complete Response in Neoadjuvant Immunotherapy.

This study tested the hypothesis that a change in the apparent diffusion coefficient (ADC) measured in diffusion-weighted MRI (DWI) is an independent imaging marker, and ADC performs better than functional tumor volume (FTV) for assessing treatment response in patients with locally advanced breast cancer receiving neoadjuvant immunotherapy. A total of 249 patients were randomized to standard neoadjuvant chemotherapy with pembrolizumab (pembro) or without pembrolizumab (control). DCE-MRI and DWI, performed prior to and 3 weeks after the start of treatment, were analyzed. Percent changes of tumor ADC metrics (mean, 5th to 95th percentiles of ADC histogram) and FTV were evaluated for the prediction of pathologic complete response (pCR) using a logistic regression model. The area under the ROC curve (AUC) estimated for the percent change in mean ADC was higher in the pembro cohort (0.73, 95% confidence interval [CI]: 0.52 to 0.93) than in the control cohort (0.63, 95% CI: 0.43 to 0.83). In the control cohort, the percent change of the 95th percentile ADC achieved the highest AUC, 0.69 (95% CI: 0.52 to 0.85). In the pembro cohort, the percent change of the 25th percentile ADC achieved the highest AUC, 0.75 (95% CI: 0.55 to 0.95). AUCs estimated for percent change of FTV were 0.61 (95% CI: 0.39 to 0.83) and 0.66 (95% CI: 0.47 to 0.85) for the pembro and control cohorts, respectively. Tumor ADC may perform better than FTV to predict pCR at an early treatment time-point during neoadjuvant immunotherapy.

Effect of Inter-Reader Variability on Diffusion-Weighted MRI Apparent Diffusion Coefficient Measurements and Prediction of Pathologic Complete Response for Breast Cancer.

This study evaluated the inter-reader agreement of tumor apparent diffusion coefficient (ADC) measurements performed on breast diffusion-weighted imaging (DWI) for assessing treatment response in a multi-center clinical trial of neoadjuvant chemotherapy (NAC) for breast cancer. DWIs from 103 breast cancer patients (mean age: 46 ± 11 years) acquired at baseline and after 3 weeks of treatment were evaluated independently by two readers. Three types of tumor regions of interests (ROIs) were delineated: multiple-slice restricted, single-slice restricted and single-slice tumor ROIs. Compared to tumor ROIs, restricted ROIs were limited to low ADC areas of enhancing tumor only. We found excellent agreement (intraclass correlation coefficient [ICC] ranged from 0.94 to 0.98) for mean ADC. Higher ICCs were observed in multiple-slice restricted ROIs (range: 0.97 to 0.98) than in other two ROI types (both in the range of 0.94 to 0.98). Among the three ROI types, the highest area under the receiver operating characteristic curves (AUCs) were observed for mean ADC of multiple-slice restricted ROIs (0.65, 95% confidence interval [CI]: 0.52-0.79 and 0.67, 95% CI: 0.53-0.81 for Reader 1 and Reader 2, respectively). In conclusion, mean ADC values of multiple-slice restricted ROI showed excellent agreement and similar predictive performance for pathologic complete response between the two readers.

Utility and Outcomes of Preoperative Screening Breast MRI for Planned Bilateral Prophylactic Mastectomy in High-Risk Patients.

BACKGROUND. There is a paucity of data and consensus guidelines on the utility of preoperative MRI for planned bilateral prophylactic mastectomy. OBJECTIVE. The purpose of this study was to evaluate the utility of breast MRI performed in high-risk patients for the indication of planned bilateral prophylactic mastectomy, with attention given to the diagnostic performance for breast cancer detection. A secondary aim was to assess the potential impact of breast MRI findings on the decision to perform sentinel lymph node biopsy at the time of prophylactic mastectomy. METHODS. A retrospective database review identified MRI examinations performed at an academic medical center from August 2003 to January 2020 for the indication of planned bilateral prophylactic mastectomy. Patient demographics, imaging findings, operative details, and pathology were recorded. BI-RADS category 1 and 2 assessments were considered negative examinations, and BI-RADS category 3, 4, and 5 assessments were considered positive examinations. Descriptive statistics and performance metrics were calculated. RESULTS. The final cohort included 53 patients (mean age, 45 years). Most (35/53; 66.0%) studies were baseline examinations. Of the 53 patients, 31 (58.5%) had negative MRI examinations and 22 (41.5%) had positive MRI examinations. MRI detected two malignancies (one invasive lobular carcinoma and one high-grade ductal carcinoma in situ), both of which were assessed as BI-RADS category 4. The patient with invasive lobular cancer underwent sentinel lymph node biopsy at the time of mastectomy, which showed metastasis. Breast MRI had sensitivity of 100.0% and specificity of 60.8% for overall breast cancer detection and sensitivity of 100.0% and specificity of 59.6% for invasive cancer detection. CONCLUSION. Preoperative MRI for planned bilateral prophylactic mastectomy detected all cancers, indicating a potential role for MRI in impacting surgical decision making. CLINICAL IMPACT. Given the high NPV for cancer, our results suggest that lymph node biopsy may be safely avoided in patients with a negative MRI examination. This is clinically relevant because sentinel nodes cannot be identified after mastectomy.

Outcomes of screening mammography performed prior to fertility treatment in women ages 40-49.

OBJECTIVE: There are currently various conflicting recommendations for breast cancer screening with mammography in women between ages 40-49. There are no specific guidelines for breast cancer screening in women of this age group prior to assisted reproductive technology (ART) for the treatment of infertility. The purpose of our study was to evaluate outcomes of screening mammography, specifically ordered for the purpose of pre-fertility treatment clearance in women aged 40-49 years old. MATERIALS AND METHODS: This was an IRB approved retrospective study of women aged 40-49 presenting for screening mammography prior to ART between January 2010 and October 2018. Clinical history, imaging, and pathology results were gathered from the electronic medical record. Descriptive statistics were performed. RESULTS: Our study cohort consisted of 118 women with a mean age of 42 years (range 40-49). Sixteen of 118 (14%) women were recalled from screening for additional diagnostic work-up. Five of the 16 (31%) were recommended for biopsy (BI-RADS 4 or 5). One of 5 biopsies yielded a malignant result (PPV 20%). Overall cancer detection rate was 0.85% or 8.5 women per 1000 women screened. The single cancer in this cohort was an ER+ PR+ HER2- invasive ductal carcinoma. CONCLUSION: Screening mammography in women 40-49 performed prior to initiation of ART may identify asymptomatic breast malignancy. In accordance with ACR and SBI guidelines to screen women of this age group, women of this age group should undergo screening mammography prior to ART.

Breast MRI during Neoadjuvant Chemotherapy: Lack of Background Parenchymal Enhancement Suppression and Inferior Treatment Response.

Background Suppression of background parenchymal enhancement (BPE) is commonly observed after neoadjuvant chemotherapy (NAC) at contrast-enhanced breast MRI. It was hypothesized that nonsuppressed BPE may be associated with inferior response to NAC. Purpose To investigate the relationship between lack of BPE suppression and pathologic response. Materials and Methods A retrospective review was performed for women with menopausal status data who were treated for breast cancer by one of 10 drug arms (standard NAC with or without experimental agents) between May 2010 and November 2016 in the Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2, or I-SPY 2 TRIAL (NCT01042379). Patients underwent MRI at four points: before treatment (T0), early treatment (T1), interregimen (T2), and before surgery (T3). BPE was quantitatively measured by using automated fibroglandular tissue segmentation. To test the hypothesis effectively, a subset of examinations with BPE with high-quality segmentation was selected. BPE change from T0 was defined as suppressed or nonsuppressed for each point. The Fisher exact test and the Z tests of proportions with Yates continuity correction were used to examine the relationship between BPE suppression and pathologic complete response (pCR) in hormone receptor (HR)-positive and HR-negative cohorts. Results A total of 3528 MRI scans from 882 patients (mean age, 48 years ± 10 [standard deviation]) were reviewed and the subset of patients with high-quality BPE segmentation was determined (T1, 433 patients; T2, 396 patients; T3, 380 patients). In the HR-positive cohort, an association between lack of BPE suppression and lower pCR rate was detected at T2 (nonsuppressed vs suppressed, 11.8% [six of 51] vs 28.9% [50 of 173]; difference, 17.1% [95% CI: 4.7, 29.5]; P = .02) and T3 (nonsuppressed vs suppressed, 5.3% [two of 38] vs 27.4% [48 of 175]; difference, 22.2% [95% CI: 10.9, 33.5]; P = .003). In the HR-negative cohort, patients with nonsuppressed BPE had lower estimated pCR rate at all points, but the P values for the association were all greater than .05. Conclusions In hormone receptor-positive breast cancer, lack of background parenchymal enhancement suppression may indicate inferior treatment response. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Philpotts in this issue.

Post-lumpectomy breast calcifications: Can original tumor features assist in determining need for biopsy?

OBJECTIVE: The objective of our study was to determine whether, in the digital era, imaging features of a primary breast tumor can be used to influence the decision to biopsy ipsilateral breast calcifications that occur following surgery in women treated with breast conservation surgery (BCS). MATERIALS AND METHODS: We retrospectively identified women treated with BCS who subsequently developed suspicious calcifications in the treated breast (BI-RADS 4 or 5) from January 2012 - December 2018. Only cases with histopathological diagnosis by stereotactic or surgical biopsy were included. Pathology reports were reviewed, and biopsy results were considered malignant if invasive carcinoma or ductal carcinoma in situ (DCIS) was found. All other results were considered benign. Fisher's exact test was done comparing frequencies of malignancy between those patients whose original tumor had calcifications versus those whose original tumors were not calcified. RESULTS: Of 90 women with suspicious calcifications on a post-BCS mammogram, 65 (72.2%) were biopsy proven benign and 25 (27.8%) were malignant. The original tumor presented without calcifications in 39 patients (43%), and 51 (57%) had calcifications with or without associated mass, focal asymmetry, or architectural distortion. New calcifications were less likely to be malignant if the original tumor presented without calcifications (5/39; 12.8%) as compared to original tumors with calcifications (20/51; 38.5%) [p-value < 0.05]. CONCLUSION: New calcifications after BCS are significantly less likely to be malignant if the original tumor presented without calcifications. However, with a PPV of 12.8%, even calcifications in a patient with a non-calcified primary tumor require biopsy.

Frequency and Outcomes of New Suspicious Lesions on Breast MRI in the Setting of Neoadjuvant Therapy.

OBJECTIVE. The purpose of this article was to determine the frequency and outcomes of new suspicious findings on breast MRI after initiation of neoadjuvant therapy. MATERIALS AND METHODS. A retrospective database review identified all breast MRI examinations performed to assess response to neoadjuvant therapy between 2010 and 2018. Cases with new suspicious lesions assessed as BI-RADS 4 or 5 and found after the initiation of neoadjuvant treatment were included. Cases with no pretreatment MRI, cases in which the suspicious lesion was present on the baseline MRI but remained suspicious, and cases with insufficient follow-up were excluded. Radiologic, pathologic, and surgical reports were reviewed. Malignant outcomes were determined by pathologic examination. Benignity was established by pathologic examination, follow-up imaging, or both. A total of 419 breast MRI examinations in 297 women were performed to assess response to neoadjuvant therapy. After exclusions, 23 MRI examinations (5.5%) with new suspicious findings, all assessed as BI-RADS 4, comprised the final cohort. RESULTS. Of the 23 lesions, 13 new suspicious findings (56.5%) were contralateral to the known malignancy, nine (39.1%) were ipsilateral, and one (4.3%) involved the bilateral breasts. Lesion types included mass (16, 69.6%), nonmass enhancement (5, 21.7%) and focus (2, 8.7%). None of the new suspicious findings were malignant. CONCLUSION. New suspicious findings occurred in 5.5% of breast MRI examinations performed to monitor response to neoadjuvant therapy, and none of these new lesions were malignant. Our findings suggest that new lesions that arise in the setting of neoadjuvant therapy are highly unlikely to represent a new site of malignancy, particularly if the index malignancy shows treatment response. Larger studies are needed to confirm whether biopsy may be safely averted in this scenario.

Intermediary clip placement to assist accurate axillary lymph node localization.

Localization of metastatic axillary lymph nodes in breast cancer patients is an increasingly common procedure performed by radiologists. In 2014, the National Comprehensive Cancer Network guidelines stated that "clinically positive axillary lymph node (s) should be sampled by FNA or core biopsy and clipped with image-detectable marker; clipped lymph nodes must be removed if FNA or core biopsy was positive prior to neoadjuvant therapy". Since then, multiple studies have further supported targeted axillary surgery after neoadjuvant chemotherapy (NAC), with excision of the clipped metastatic axillary node in addition to the sentinel node (s). Requests for image guided localization of clipped axillary nodes will continue to increase and likely become the standard of care. However, when lymph nodes have decreased in size after NAC, or when small deep lymph nodes are sampled, the clipped node can be difficult to identify under ultrasound at the time of localization. When the target node is questionable, we have found it valuable to place an intermediary clip, and use an axillary mammographic view to confirm this intermediary clip co-localizes with the intended target. With this confirmation, safe, accurate localization can then be performed. We describe 3 cases of intermediary clip placement facilitating successful localization of previously clipped axillary lymph nodes.

Predicting breast cancer response to neoadjuvant treatment using multi-feature MRI: results from the I-SPY 2 TRIAL.

Dynamic contrast-enhanced (DCE) MRI provides both morphological and functional information regarding breast tumor response to neoadjuvant chemotherapy (NAC). The purpose of this retrospective study is to test if prediction models combining multiple MRI features outperform models with single features. Four features were quantitatively calculated in each MRI exam: functional tumor volume, longest diameter, sphericity, and contralateral background parenchymal enhancement. Logistic regression analysis was used to study the relationship between MRI variables and pathologic complete response (pCR). Predictive performance was estimated using the area under the receiver operating characteristic curve (AUC). The full cohort was stratified by hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status (positive or negative). A total of 384 patients (median age: 49 y/o) were included. Results showed analysis with combined features achieved higher AUCs than analysis with any feature alone. AUCs estimated for the combined versus highest AUCs among single features were 0.81 (95% confidence interval [CI]: 0.76, 0.86) versus 0.79 (95% CI: 0.73, 0.85) in the full cohort, 0.83 (95% CI: 0.77, 0.92) versus 0.73 (95% CI: 0.61, 0.84) in HR-positive/HER2-negative, 0.88 (95% CI: 0.79, 0.97) versus 0.78 (95% CI: 0.63, 0.89) in HR-positive/HER2-positive, 0.83 (95% CI not available) versus 0.75 (95% CI: 0.46, 0.81) in HR-negative/HER2-positive, and 0.82 (95% CI: 0.74, 0.91) versus 0.75 (95% CI: 0.64, 0.83) in triple negatives. Multi-feature MRI analysis improved pCR prediction over analysis of any individual feature that we examined. Additionally, the improvements in prediction were more notable when analysis was conducted according to cancer subtype.

Primum non nocere: Utility and outcomes of pediatric breast ultrasound.

PURPOSE: To assess the use and outcomes of ultrasound for the evaluation of breast signs and symptoms in pediatric females. METHODS: A retrospective database review identified all patients ≤18-years-old who underwent breast ultrasound at an academic institution over a 20-year period. Each symptomatic site was designated a case and analyses were performed on each case. Imaging findings were obtained from the radiology reports. Clinical and pathology data were obtained from the medical records. Descriptive statistics were performed. RESULTS: The final cohort comprised 124 cases in 101 patients. Mean age was 15 years (range 1-18). The most common indication for ultrasound was a palpable lump (71%). Thirty-seven cases (30%) demonstrated no sonographic correlate to the symptom; 36 (29%) had a benign correlate. The most common benign correlates were abscess/phlegmon and cyst. All cases of abscess/phlegmon had infectious symptoms. Fifty-one cases (41%) demonstrated a sonographic mass that was not characteristically benign. Of these indeterminate masses, 27 were recommended for biopsy, 13 for short-interval follow-up, and 6 had no recommendation. Of 27 biopsied masses, 63% were fibroadenomas. No symptoms were due to malignancy. Therefore, the NPV of ultrasound was 100% and the PPV 0%. CONCLUSION: In this cohort of pediatric and adolescent patients, malignancy was never the cause of breast symptoms. Imaging yielded false positives with a biopsy recommendation in 22% of cases. Ultrasound provided value in evaluating infectious symptoms. Given the extreme rarity of breast cancer in this population, surveillance may be a safe alternative for most indeterminate lesions.

Performance of screening MRI in high risk patients at initial versus subsequent screen.

PURPOSE: To compare the characteristics, outcomes, and performance metrics in women undergoing initial breast MRI screening versus subsequent screening. METHODS: A retrospective database search identified screening MRIs performed at an academic practice from 2013 to 2015. MRIs were divided into two groups: (1) initial screens and (2) subsequent screens (interpreted with at least one prior MRI for comparison). Benignity was confirmed with pathology or >1-year follow-up. Malignancy was confirmed by pathology. Performance metrics were calculated. Comparisons were made using Binomial and Fisher's exact tests. RESULTS: We observed a higher rate of abnormal interpretations (52% vs. 19%; p < 0.001) and rate of biopsy (49% vs. 15%; p < 0.001) in the initial versus subsequent screen group. The positive predictive value of biopsy was slightly lower at initial versus subsequent screen (17% vs. 19%, p = 0.99). However, the cancer detection rate was higher at initial than at subsequent screen (85 vs. 29/1000, p = 0.08). Sensitivity was higher at initial (100%) versus subsequent (88%) screen. However, the specificity at initial screen was low (55%) compared to subsequent screen (83%). CONCLUSIONS: The higher rate of abnormal interpretations in the initial versus subsequent screen group in part reflects a prevalence screening. Although we observed more abnormal interpretations in the initial screen, this was likely justified by the significantly higher cancer detection. This evidence may be used to counsel patients and referring providers on the expected higher likelihood of recall from an initial screening MRI balanced with higher detection of malignancies. Findings also highlight the importance of having comparison MRIs to decrease false positives.

Phase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor-Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance).

PURPOSE: Primary endocrine therapy for ductal carcinoma in situ (DCIS) as a potential alternative to surgery has been understudied. This trial explored the feasibility of a short-term course of letrozole and sought to determine whether treatment results in measurable radiographic and biologic changes in estrogen receptor (ER)-positive DCIS. PATIENTS AND METHODS: A phase II single-arm multicenter cooperative-group trial was conducted in postmenopausal patients diagnosed with ER-positive DCIS without invasion. Patients were treated with letrozole 2.5 mg per day for 6 months before surgery. Breast magnetic resonance imaging (MRI) was obtained at baseline, 3 months, and 6 months. The primary end point was change in 6-month MRI enhancement volume compared with baseline. RESULTS: Overall, 79 patients were enrolled and 70 completed 6 months of letrozole. Of these, 67 patients had MRI data available for each timepoint. Baseline MRI volumes ranged from 0.004 to 26.3 cm3. Median reductions from baseline MRI volume (1.4 cm3) were 0.6 cm3 (61.0%) at 3 months (P < .001) and 0.8 cm3 (71.7%) at 6 months (P < .001). Consistent reductions were seen in median baseline ER H-score (228; median reduction, 15.0; P = .005), progesterone receptor H-score (15; median reduction, 85.0; P < .001), and Ki67 score (12%; median reduction, 6.3%; P = .007). Of the 59 patients who underwent surgery per study protocol, persistent DCIS remained in 50 patients (85%), invasive cancer was detected in six patients (10%), and no residual DCIS or invasive cancer was seen in nine patients (15%). CONCLUSIONS: In a cohort of postmenopausal women with ER-positive DCIS, preoperative letrozole resulted in significant imaging and biomarker changes. These findings support future trials of extended endocrine therapy as primary nonoperative treatment of some DCIS.

Utility of Diagnostic Mammography as the Primary Imaging Modality for Palpable Lumps in Women With Almost Entirely Fatty Breasts.

OBJECTIVE. The purpose of this study was to assess the performance of diagnostic mammography alone for evaluation of palpable symptoms in women with almost entirely fatty breast composition. MATERIALS AND METHODS. All diagnostic mammograms performed for palpable symptoms in women who had been assigned a breast density of "almost entirely fatty" over an 8-year period (2009-2017) at an academic breast center were retrospectively identified. Each symptomatic breast was considered a separate case and analyses were performed at the case level. Clinical, imaging, and pathologic results were reviewed. Descriptive statistics and 2 × 2 contingency table analyses were performed. RESULTS. The study cohort included 323 cases evaluated with mammography. Of these, 294 (91%) had undergone targeted ultrasound. At mammography, 240 (74%) had no correlate to the palpable lump; 38 (12%), a benign correlate; and 45 (14%), a suspicious correlate. Three cases had incidental suspicious mammographic findings, for a total of 48 positive mammography cases. Twenty-seven (8%) cases were malignant. Mammography alone detected all but one cancer, which was detected by ultrasound. In retrospect, the woman from whom this single false-negative mammogram was obtained did not have almost entirely fatty breast density. Mammography alone yielded a negative predictive value of 99.6%, percentage of diagnostic examinations recommended for biopsy that resulted in a tissue diagnosis of malignancy within 1 year of 54%, sensitivity of 96%, and specificity of 93%. Adjunct ultrasound contributed to 11 false-positives but also identified benign correlates in eight cases with no mammographic finding. CONCLUSION. In patients with almost entirely fatty breast tissue presenting with palpable symptoms, mammography alone had a high sensitivity and specificity. Our results support that mammography alone may be sufficient for evaluation of palpable symptoms in these women as long as density criteria are strictly applied.

Outcomes of screening mammography in women less than 40 prior to fertility treatment: a retrospective pilot study.

OBJECTIVE: There are currently no evidence-based guidelines regarding breast cancer screening in women under 40 prior to initiating assisted reproductive technology (ART). The prevalence of abnormal findings on screening mammography in this population is unknown. The purpose of this study was to describe screening mammography outcomes in women less than 40 years old, referred for the indication of pre-ART. MATERIALS, METHODS, PROCEDURES: This is a retrospective review of women less than 40 years old presenting for screening mammography prior to ART between January 2010 and March 2017. Clinical history, breast cancer risk factors, imaging and pathology results were gathered from the electronic medical record. RESULTS: The study included 80 women. Mean patient age was 37 years (range 34-39 years). Sixty-seven (84%) had negative or benign screening (BI-RADS 1 or 2) and 13 (16%) were recalled for diagnostic imaging (BI-RADS 0). Four of 13 (31%) recalled women were given BI-RADS 1 or 2 at diagnostic work-up, 4 (31%) were given a BI-RADS 3, and 5 (38%) were recommended for biopsy (BI-RADS 4). At patient request, 2 of 4 (50%) BI-RADS 3 cases underwent biopsy, for 7 total biopsies. Six (86%) biopsies yielded benign results and 1 (14%) yielded DCIS. Overall cancer yield was 1.3%. CONCLUSION: In women under 40 who plan to undergo ART, screening mammography may identify breast malignancies. This may be of particular importance given many breast cancers are hormone sensitive, and thus fertility treatments may affect tumor growth. Future, larger studies are needed.

Superparamagnetic Iron Oxide Sentinel Node Tracer Injection: Effects on Breast MRI Quality.

OBJECTIVE: To evaluate the MRI artifact rendered by the typical injection of a ferromagnetic tracer now being intermittently used for intraoperative sentinel node (SN) identification at our institution, and to explore its impact on postoperative imaging and management. METHODS: This study was Institutional Review Board-approved and granted a waiver of consent. A database search tool was used to identify MRI exams performed on patients who had previously undergone breast-conserving surgery with use of a superparamagnetic iron oxide (SPIO) SN tracer between January 1, 2015, and May 1, 2020. MRI reports, images, and relevant demographic, oncologic, and surgical history were collected. The presence or absence of SPIO residue on breast MRI, as well as its impact on image quality, were extracted from the prospective reports. RESULTS: A total of 21 MRI exams were identified in 16 patients who had undergone breast-conservation therapy for cancer with use of SPIO SN tracer. Mean time from particle injection to baseline postoperative MRI exam was 10.8 months. All reports (21/21) noted evidence of SPIO residue. Of these, 5/21 were assessed as non-diagnostic; the remainder were assessed as limited. CONCLUSION: Radiologists should be aware of the use of superparamagnetic tracers for SN identification and the impact on the quality of future MRI examinations. Alternative injection approaches are being developed and sequence parameters adjusted to minimize artifact.

Utilization of Patient Navigators in Breast Imaging Facilities Across the United States: A Survey of Breast Imaging Radiologists.

OBJECTIVE: To assess the utilization of patient navigators at breast imaging facilities across the United States. METHODS: An online survey was distributed to physician members of the Society of Breast Imaging. Questions encompassed use of patient navigators in breast imaging including: presence and qualifications, roles in patient care, perceived benefits, and barriers. Data were analyzed to identify the overall prevalence of patient navigators, their responsibilities and qualifications, and the impact on breast imaging centers. RESULTS: Three-hundred and eighty-five board-certified radiologists practicing in the United States completed the survey. The most common practice types were private practice (52%; 201/385) and academic (29%; 110/385). The majority (67%; 256/385) employed navigators, and the most common qualification was a registered nurse (78%; 200/256). Navigators were used for a variety of patient communication and care coordination roles, most commonly to provide educational resources (86%; 219/256), assist patients with scheduling appointments (80%; 205/256), explain the biopsy process (76%;195/256), and communicate biopsy results (64%). Nearly all (99%; 254/256) respondents ranked patient navigators as valuable to extremely valuable in improving patient care and indicated they would recommend implementation of a patient navigation program to other breast imaging practices. The most common barrier to employing a navigator was the financial cost. CONCLUSION: Patient navigators have been widely adopted in breast imaging practices across the United States, with two-thirds of respondents reporting use of a navigator. Although navigator roles varied by practice, nearly all radiologists utilizing patient navigators found that they positively impact patient care and would recommend them to other breast imaging practices.