Diagnostic accuracy of supplemental three-dimensional breast ultrasound in the work-up of BI-RADS 0 screening recalls.

OBJECTIVE: To evaluate the diagnostic accuracy of supplemental 3D automated breast ultrasound (ABUS) in the diagnostic work-up of BI-RADS 0 recalls. We hypothesized that 3D ABUS may reduce the benign biopsy rate. MATERIALS AND METHODS: In this prospective multicenter diagnostic study, screening participants recalled after a BI-RADS 0 result underwent bilateral 3D ABUS supplemental to usual care: digital breast tomosynthesis (DBT) and targeted hand-held ultrasound (HHUS). Sensitivity, specificity, positive predictive value, and negative predictive value of 3D ABUS, and DBT plus HHUS, were calculated. New 3D ABUS findings and changes of management (biopsy or additional imaging) were recorded. RESULTS: A total of 501 women (median age 55 years, IQR [51-64]) with 525 BI-RADS 0 lesions were included between April 2018 and March 2020. Cancer was diagnosed in 45 patients. 3D ABUS sensitivity was 72.1% (95% CI [57.2-83.4%]), specificity 84.4% (95% CI [80.8-87.4%]), PPV 29.2% (95% CI [21.4-38.5%]), and NPV 97.1% 95.0-98.4%). Sensitivity of DBT plus HHUS was 100% (95% CI [90.2-100%]), specificity 71.4% (95% CI [67.2-75.2%]), PPV 23.8% (95% CI [18.1-30.5%]) and NPV 100% (95% CI [98.7-100%]). Twelve out of 43 (27.9%) malignancies in BI-RADS 0 lesions were missed on 3D ABUS, despite being detected on DBT and/or HHUS. Supplemental 3D ABUS resulted in the detection of 57 new lesions and six extra biopsy procedures, all were benign. CONCLUSION: 3D ABUS in the diagnostic work-up of BI-RADS 0 recalls may miss over a quarter of cancers detected with HHUS and/or DBT and should not be used to omit biopsy. Supplemental 3D ABUS increases the benign biopsy rate. TRIAL REGISTRATION: Dutch Trial Register, available via https://www.onderzoekmetmensen.nl/en/trial/29659 CRITICAL RELEVANCE STATEMENT: Supplemental 3D automated breast ultrasound in the work-up of BI-RADS 0 recalls may miss over a quarter of cancers detected with other methods and should not be used to omit biopsy; ABUS findings did increase benign biopsy rate. KEY POINTS: Automated breast ultrasound (ABUS) may miss over 25% of cancers detectable by alternative methods. Don't rely solely on 3D ABUS to assess indication for biopsy. New findings with supplemental 3D ABUS increase the benign biopsy rate.

Radiofrequency localization of nonpalpable breast cancer in a multicentre prospective cohort study: feasibility, clinical acceptability, and safety.

PURPOSE: In breast conserving surgery, accurate lesion localization is essential for obtaining adequate surgical margins. Preoperative wire localization (WL) and radioactive seed localization (RSL) are widely accepted methods to guide surgical excision of nonpalpable breast lesions but are limited by logistical challenges, migration issues, and legislative complexities. Radiofrequency identification (RFID) technology may offer a viable alternative. The purpose of this study was to evaluate the feasibility, clinical acceptability, and safety of RFID surgical guidance for localization of nonpalpable breast cancer. METHODS: In a prospective multicentre cohort study, the first 100 RFID localization procedures were included. The primary outcome was the percentage of clear resection margins and re-excision rate. Secondary outcomes included procedure details, user experience, learningcurve, and adverse events. RESULTS: Between April 2019 and May 2021, 100 women underwent RFID guided breast conserving surgery. Clear resection margins were obtained in 89 out of 96 included patients (92.7%), re-excision was indicated in three patients (3.1%). Radiologists reported difficulties with the placement of the RFID tag, partially related to the relatively large needle-applicator (12-gauge). This led to the premature termination of the study in the hospital using RSL as regular care. The radiologist experience was improved after a manufacturer modification of the needle-applicator. Surgical localization involved a low learning curve. Adverse events (n = 33) included dislocation of the marker during insertion (8%) and hematomas (9%). The majority of adverse events (85%) occurred using the first-generation needle-applicator. CONCLUSION: RFID technology is a potential alternative for non-radioactive and non-wire localization of nonpalpable breast lesions.

A multicenter prospective cohort study to evaluate feasibility of radio-frequency identification surgical guidance for nonpalpable breast lesions: design and rationale of the RFID Localizer 1 Trial.

BACKGROUND: Breast cancer screening and improving imaging techniques have led to an increase in the detection rate of early, nonpalpable breast cancers. For early breast cancer, breast conserving surgery is an effective and safe treatment. Accurate intraoperative lesion localization during breast conserving surgery is essential for adequate surgical margins while sparing surrounding healthy tissue to achieve optimal cosmesis. Preoperative wire localization and radioactive seed localization are accepted standard methods to guide surgical excision of nonpalpable breast lesions. However, these techniques present significant limitations. Radiofrequency identification (RFID) technology offers a new, nonradioactive method for localizing nonpalpable breast lesions in patients undergoing breast conserving surgery. This study aims to evaluate the feasibility of RFID surgical guidance for nonpalpable breast lesions. METHODS: This multicenter prospective cohort study was approved by the Institutional Review Board of the University Medical Center Utrecht. Written informed consent is obtained from all participants. Women with nonpalpable, histologically proven in situ or invasive breast cancer, who can undergo breast conserving surgery with RFID localization are considered eligible for participation. An RFID tag is placed under ultrasound guidance, up to 30 days preoperatively. The surgeon localizes the RFID tag with a radiofrequency reader that provides audible and visual real-time surgical guidance. The primary study outcome is the percentage of irradical excisions and reexcision rate, which will be compared to standards of the National Breast Cancer Organisation Netherlands (NABON)(≤ 15% irradical excisions of invasive carcinomas). Secondary outcomes include user acceptability/experiences, learning curve, duration and ease of the placement- and surgical procedure and adverse events. DISCUSSION: This study evaluates the feasibility of RFID surgical guidance for nonpalpable breast lesions. Results may have implications for the future localization techniques in women with nonpalpable breast cancer undergoing breast conserving surgery. TRIAL REGISTRATION: Netherlands National Trial Register, NL8019 , registered on September 12th 2019.

A 67-Year-Old Male Patient With COVID-19 With Worsening Respiratory Function and Acute Kidney Failure.

CASE PRESENTATION: A 67-year-old obese man (BMI 38.0) with type 2 diabetes mellitus (DM), chronic atrial fibrillation, and chronic lymphocytic leukemia stage II, stable for 8 years after chemotherapy, and a history of smoking presented to the ED with progressive dyspnea and fever due to SARS-CoV-2 infection. He was admitted to a general ward and treated with dexamethasone (6 mg IV once daily) and oxygen. On day 3 of hospital admission, he became progressively hypoxemic and was admitted to the ICU for invasive mechanical ventilation. Dexamethasone treatment was continued, and a single dose of tocilizumab (800 mg) was administered. On day 9 of ICU admission, voriconazole treatment was initiated after tracheal white plaques at bronchoscopy, suggestive of invasive Aspergillus tracheobronchitis, were noticed. However, his medical situation dramatically deteriorated.

Reducing False-Positive Screening MRI Rate in Women with Extremely Dense Breasts Using Prediction Models Based on Data from the DENSE Trial.

Background High breast density increases breast cancer risk and lowers mammographic sensitivity. Supplemental MRI screening improves cancer detection but increases the number of false-positive screenings. Thus, methods to distinguish true-positive MRI screening results from false-positive ones are needed. Purpose To build prediction models based on clinical characteristics and MRI findings to reduce the rate of false-positive screening MRI findings in women with extremely dense breasts. Materials and Methods Clinical characteristics and MRI findings in Dutch breast cancer screening participants (age range, 50-75 years) with positive first-round MRI screening results (Breast Imaging Reporting and Data System 3, 4, or 5) after a normal screening mammography with extremely dense breasts (Volpara density category 4) were prospectively collected within the randomized controlled Dense Tissue and Early Breast Neoplasm Screening (DENSE) trial from December 2011 through November 2015. In this secondary analysis, prediction models were built using multivariable logistic regression analysis to distinguish true-positive MRI screening findings from false-positive ones. Results Among 454 women (median age, 52 years; interquartile range, 50-57 years) with a positive MRI result in a first supplemental MRI screening round, 79 were diagnosed with breast cancer (true-positive findings), and 375 had false-positive MRI results. The full prediction model (area under the receiver operating characteristics curve [AUC], 0.88; 95% CI: 0.84, 0.92), based on all collected clinical characteristics and MRI findings, could have prevented 45.5% (95% CI: 39.6, 51.5) of false-positive recalls and 21.3% (95% CI: 15.7, 28.3) of benign biopsies without missing any cancers. The model solely based on readily available MRI findings and age had a comparable performance (AUC, 0.84; 95% CI: 0.79, 0.88; P = .15) and could have prevented 35.5% (95% CI: 30.4, 41.1) of false-positive MRI screening results and 13.0% (95% CI: 8.8, 18.6) of benign biopsies. Conclusion Prediction models based on clinical characteristics and MRI findings may be useful to reduce the false-positive first-round screening MRI rate and benign biopsy rate in women with extremely dense breasts. Clinical trial registration no. NCT01315015 © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Imbriaco in this issue.

Patients' perceptions of 70-gene signature testing: commonly changing the initial inclination to undergo or forego chemotherapy and reducing decisional conflict.

PURPOSE: Little is known about the impact of 70-gene signature (70-GS) use on patients' chemotherapy decision-making. The primary aim of this study was to evaluate the impact of 70-GS use on patients' decisions to undergo chemotherapy. The perceived decision conflict during decision-making was a secondary objective of the study. METHODS: Patients operated for estrogen receptor positive early breast cancer were asked to fill out a questionnaire probing their inclination to undergo chemotherapy before deployment of the 70-GS test. After disclosure of the 70-GS result patients were asked about their decision regarding chemotherapy. Patients' decisional conflict was measured using the 16-item decisional conflict scale (DCS); scores < 25 are associated with a persuaded decision while a score > 37.5 implies that one feels unsure about a choice. RESULTS: Between January 1th 2017 and December 31th 2018, 106 patients completed both questionnaires. Before deployment of the 70-GS, 58% of patients (n = 62) formulated a clear treatment preference, of whom 21 patients (34%) changed their opinion on treatment with chemotherapy following the 70-GS. The final decision regarding chemotherapy was in line with the 70-GS result in 90% of patients. The percentage of patients who felt unsure about their preference to be treated with chemotherapy decreased from 42 to 5% after disclosure of the 70-GS. The mean total DCS significantly decreased from pre-test to post-test from 35 to 23, irrespective of the risk estimate (p < 0.001). CONCLUSION: Deployment of the 70-GS changed patients' inclination to undergo adjuvant chemotherapy in one third of patients and decreased patients' decisional conflict.

Stereotactic 9-gauge vacuum-assisted breast biopsy, how many specimens are needed?

PURPOSE: To determine the minimum number of stereotactic 9-gauge vacuum-assisted biopsy specimens required to establish a final histopathological biopsy diagnosis of mammographically suspicious breast lesions. METHODS: This prospective single-center observational cohort study included 120 women referred for stereotactic vacuum-assisted biopsy of 129 mammographically suspicious lesions between December 2017 and October 2018. Stereotactic 9-gauge vacuum-assisted biopsy was performed, acquiring twelve specimens per lesion. Calcification retrieval was assessed with individual specimen radiography. Each specimen was histologically analyzed in chronological order and findings were compared with the final histopathological result after assessment of all twelve specimens and with results of surgical excision. Cumulative diagnostic yield per specimen was calculated. RESULTS: In total, 131 biopsy procedures were performed in 120 women (mean age 59 years). In 95% (95%CI 90%-98%) of the procedures a final histopathological diagnosis was reached after six specimens. After nine specimens the final biopsy diagnosis was established in all 131 cases. In the subgroup of 41 patients with a DCIS or invasive diagnosis at biopsy there were eight procedures (20%) where calcifications were retrieved before the diagnostic specimen was obtained. Underestimation of subsequent resection diagnosis occurred in six out of 30 excised lesions classified as DCIS (20%) and in one out of four excised high-risk lesions. CONCLUSIONS: With six stereotactic 9-gauge vacuum-assisted biopsy specimens a final histopathological biopsy diagnosis could be established in 95% (95%CI 90%-98%) of the biopsy procedures. Taking nine 9-gauge specimens seems to be optimal. Ending the stereotactic vacuum-assisted breast biopsy procedure as soon as calcifications are retrieved may cause false negative results.