The FDA Enhancing Quality Using the Inspection Program (EQUIP) Breast Imaging Quality Initiative. 5-Year Clinical Experience.

OBJECTIVES: To evaluate the effects of the Enhancing Quality Using the Inspection Program (EQUIP) on quality control (QC) and quality assurance (QA) at an academic medical center. METHODS: EQUIP audit logs for technologist image quality review as well as mammography unit QA and QC formed the basis for study data. One randomly selected screening mammogram was evaluated by the lead interpreting physician (LIP) using EQUIP criteria for each technologist for each imaging site worked, initially semiannually and then monthly. One randomly selected screening mammogram interpreted by each interpreting physician (IP) for each imaging site was evaluated on a semiannual basis. Quarterly, the LIP reviewed QA and QC logs for each mammography unit with deficiencies further investigated. RESULTS: Of 214 965 eligible screening mammograms performed, 5955 (2.8%) underwent EQUIP image quality review. Five were found to be technically inadequate (0.08%, 5955/214 965). The LIP identified 20 significant interpretive differences compared with the clinical interpretation resulting in 10 biopsies and 7 previously undetected malignancies, with supplemental cancer detection rate of 1.2/1000 cases reviewed. Two hundred ninety mammography unit QA/QC reviews identified 31 potential deficiencies, 29 of which were due to human documentation error (93.4%). CONCLUSION: EQUIP review of both IP and technologists' quality and mammography unit QA/QC logs as performed identified few deficiencies. EQUIP policies should be evaluated at each institution and modified to best utilize resources and provide opportunities for meaningful quality improvement. Although not an EQUIP focus, supplemental cancer detection was observed as might be expected with double reading.

Artificial Intelligence Applications in Breast Imaging: Current Status and Future Directions.

Attempts to use computers to aid in the detection of breast malignancies date back more than 20 years. Despite significant interest and investment, this has historically led to minimal or no significant improvement in performance and outcomes with traditional computer-aided detection. However, recent advances in artificial intelligence and machine learning are now starting to deliver on the promise of improved performance. There are at present more than 20 FDA-approved AI applications for breast imaging, but adoption and utilization are widely variable and low overall. Breast imaging is unique and has aspects that create both opportunities and challenges for AI development and implementation. Breast cancer screening programs worldwide rely on screening mammography to reduce the morbidity and mortality of breast cancer, and many of the most exciting research projects and available AI applications focus on cancer detection for mammography. There are, however, multiple additional potential applications for AI in breast imaging, including decision support, risk assessment, breast density quantitation, workflow and triage, quality evaluation, response to neoadjuvant chemotherapy assessment, and image enhancement. In this review the current status, availability, and future directions of investigation of these applications are discussed, as well as the opportunities and barriers to more widespread utilization.

Sentinel node mapping and biopsy in ectopic axillary breast cancer: A case report and review of the literature.

Sentinel lymph node mapping in patients with axillary breast carcinoma is technically challenging and poorly described in the literature. We report a patient with primary ectopic breast carcinoma of the axilla in whom concurrent peri-tumoral and intra-tumoral injection of radionuclide tracer allowed for identification and biopsy of sentinel lymph nodes.

Long-term safety and efficacy of breast biopsy markers in clinical practice.

Objective: Percutaneous breast and axillary core biopsy followed by marker placement are integral parts of a breast imager's practice benefiting both patients and clinicians. Marker placement is the standard to facilitate future care. The purpose of this study is to characterize the safety and performance of MammoMARK, CorMARK, and HydroMARK biopsy markers by evaluating device-related adverse events, device deficiencies, and long-term safety.Methods: A retrospective review of three radiology practices identified patients who underwent image-guided breast or axillary biopsies followed by marker placement between 1 January 2012 and 1 January 2017. Medical records were reviewed with adverse events related to marker placement and use recorded.Results: 768 markers were placed with three (0.4%) events recorded. Two device deficiencies and one non-serious adverse event occurred in three patients. Device deficiency events involved user errors deploying the markers, one to inability to locate the marker on post-biopsy imaging, and the second to misplacement relative to biopsy target. One non-serious adverse event involved inability to locate/retain the marker in a surgically resected specimen. No serious adverse events were reported.Conclusion: Placement of breast biopsy markers is safe with minimal associated risks. Issues related to device malfunction, durability, reliability, safety, or performance were not reported.

Diagnostic Accuracy of Digital Breast Tomosynthesis in the Evaluation of Palpable Breast Abnormalities.

RATIONALE AND OBJECTIVES: The role of digital breast tomosynthesis (DBT) in evaluating palpable abnormalities has not been evaluated and its accuracy compared to 2D mammography is unknown. The purpose of this study was to evaluate combined 2D mammography, DBT, and ultrasound (US) at palpable sites. MATERIALS AND METHODS: Two breast imagers reviewed blinded consecutive cases with combined 2D mammograms and DBT examinations performed for palpable complaints. By consensus, 2D and DBT findings were recorded and compared to US. Patient characteristics, demographics, subsequent workup, and outcome were recorded. RESULTS: A total of 229 sites in 188 patients were included, with 50 biopsies performed identifying 18 cancers. All 18 cancers were identified on 2D and US, whereas 17 cancers were identified on DBT. Cancer detection sensitivities for 2D, DBT, and US were 100.0%, 94.4%, and 100.0%. The negative predictive value, when combined with US, was 100% for both. The sensitivity and the specificity for both benign and malignant findings with 2D and DBT were 70.5% versus 75.4% (P = 0.07) and 95.3% versus 99.1% (P = 0.125). Palpable findings not identified by 2D and DBT were smaller than those identified (11.5 ± 8.3 mm vs 23.9 ± 12.8 mm, P < 0.001). Patients with dense breasts were more likely to have mammographically occult findings than patients with nondense breasts (27.4% vs 8.3%). CONCLUSIONS: DBT did not improve cancer detection over 2D or US. Both mammographic modalities failed to identify sonographically confirmed findings primarily in dense breasts. The diagnostic use of DBT at palpable sites provided limited benefit over combined 2D and US. When utilizing DBT, US should be performed to adequately characterize palpable sites.

Influences of Radiology Trainees on Screening Mammography Interpretation.

PURPOSE: Participation of radiology trainees in screening mammographic interpretation is a critical component of radiology residency and fellowship training. The aim of this study was to investigate and quantify the effects of trainee involvement on screening mammographic interpretation and diagnostic outcomes. METHODS: Screening mammograms interpreted at an academic medical center by six dedicated breast imagers over a three-year period were identified, with cases interpreted by an attending radiologist alone or in conjunction with a trainee. Trainees included radiology residents, breast imaging fellows, and fellows from other radiology subspecialties during breast imaging rotations. Trainee participation, patient variables, results of diagnostic evaluations, and pathology were recorded. RESULTS: A total of 47,914 mammograms from 34,867 patients were included, with an overall recall rate for attending radiologists reading alone of 14.7% compared with 18.0% when involving a trainee (P < .0001). Overall cancer detection rate for attending radiologists reading alone was 5.7 per 1,000 compared with 5.2 per 1,000 when reading with a trainee (P = .517). When reading with a trainee, dense breasts represented a greater portion of recalls (P = .0001), and more frequently, greater than one abnormality was described in the breast (P = .013). Detection of ductal carcinoma in situ versus invasive carcinoma or invasive cancer type was not significantly different. The mean size of cancers in patients recalled by attending radiologists alone was smaller, and nodal involvement was less frequent, though not statistically significantly. CONCLUSIONS: These results demonstrate a significant overall increase in recall rate when interpreting screening mammograms with radiology trainees, with no change in cancer detection rate. Radiology faculty members should be aware of this potentiality and mitigate tendencies toward greater false positives.