Prospective Multicenter Diagnostic Performance of Technologist-Performed Screening Breast Ultrasound After Tomosynthesis in Women With Dense Breasts (the DBTUST).

PURPOSE: To assess diagnostic performance of digital breast tomosynthesis (DBT) alone or combined with technologist-performed handheld screening ultrasound (US) in women with dense breasts. METHODS: In an institutional review board-approved, Health Insurance Portability and Accountability Act-compliant multicenter protocol in western Pennsylvania, 6,179 women consented to three rounds of annual screening, interpreted by two radiologist observers, and had appropriate follow-up. Primary analysis was based on first observer results. RESULTS: Mean participant age was 54.8 years (range, 40-75 years). Across 17,552 screens, there were 126 cancer events in 125 women (7.2/1,000; 95% CI, 5.9 to 8.4). In year 1, DBT-alone cancer yield was 5.0/1,000, and of DBT+US, 6.3/1,000, difference 1.3/1,000 (95% CI, 0.3 to 2.1; P = .005). In years 2 + 3, DBT cancer yield was 4.9/1,000, and of DBT+US, 5.9/1,000, difference 1.0/1,000 (95% CI, 0.4 to 1.5; P < .001). False-positive rate increased from 7.0% for DBT in year 1 to 11.5% for DBT+US and from 5.9% for DBT in year 2 + 3 to 9.7% for DBT+US (P < .001 for both). Nine cancers were seen only by double reading DBT and one by double reading US. Ten interval cancers (0.6/1,000 [95% CI, 0.2 to 0.9]) were identified. Despite reduction in specificity, addition of US improved receiver operating characteristic curves, with area under receiver operating characteristic curve increasing from 0.83 for DBT alone to 0.92 for DBT+US in year 1 (P = .01), with smaller improvements in subsequent years. Of 6,179 women, across all 3 years, 172/6,179 (2.8%) unique women had a false-positive biopsy because of DBT as did another 230/6,179 (3.7%) women because of US (P < .001). CONCLUSION: Overall added cancer detection rate of US screening after DBT was modest at 19/17,552 (1.1/1,000; CI, 0.5- to 1.6) screens but potentially overcomes substantial increases in false-positive recalls and benign biopsies.

Impact of Original and Artificially Improved Artificial Intelligence-based Computer-aided Diagnosis on Breast US Interpretation.

OBJECTIVE: For breast US interpretation, to assess impact of computer-aided diagnosis (CADx) in original mode or with improved sensitivity or specificity. METHODS: In this IRB approved protocol, orthogonal-paired US images of 319 lesions identified on screening, including 88 (27.6%) cancers (median 7 mm, range 1-34 mm), were reviewed by 9 breast imaging radiologists. Each observer provided BI-RADS assessments (2, 3, 4A, 4B, 4C, 5) before and after CADx in a mode-balanced design: mode 1, original CADx (outputs benign, probably benign, suspicious, or malignant); mode 2, artificially-high-sensitivity CADx (benign or malignant); and mode 3, artificially-high-specificity CADx (benign or malignant). Area under the receiver operating characteristic curve (AUC) was estimated under each modality and for standalone CADx outputs. Multi-reader analysis accounted for inter-reader variability and correlation between same-lesion assessments. RESULTS: AUC of standalone CADx was 0.77 (95% CI: 0.72-0.83). For mode 1, average reader AUC was 0.82 (range 0.76-0.84) without CADx and not significantly changed with CADx. In high-sensitivity mode, all observers' AUCs increased: average AUC 0.83 (range 0.78-0.86) before CADx increased to 0.88 (range 0.84-0.90), P < 0.001. In high-specificity mode, all observers' AUCs increased: average AUC 0.82 (range 0.76-0.84) before CADx increased to 0.89 (range 0.87-0.92), P < 0.0001. Radiologists responded more frequently to malignant CADx cues in high-specificity mode (42.7% vs 23.2% mode 1, and 27.0% mode 2, P = 0.008). CONCLUSION: Original CADx did not substantially impact radiologists' interpretations. Radiologists showed improved performance and were more responsive when CADx produced fewer false-positive malignant cues.

Contrast Enhanced Digital Mammography (CEDM) Helps to Safely Reduce Benign Breast Biopsies for Low to Moderately Suspicious Soft Tissue Lesions.

RATIONALE AND OBJECTIVES: To preliminarily asses if Contrast Enhanced Digital Mammography (CEDM) can accurately reduce biopsy rates for soft tissue BI-RADS 4A or 4B lesions. MATERIALS AND METHODS: Eight radiologists retrospectively and independently reviewed 60 lesions in 54 consenting patients who underwent CEDM under Health Insurance Portability and Accountability Act compliant institutional review board-approved protocols. Readers provided Breast Imaging Reporting & Data System ratings sequentially for digital mammography/digital breast tomosynthesis (DM/DBT), then with ultrasound, then with CEDM for each lesion. Area under the curve (AUC), true positive rates and false positive rates, positive predictive values and negative predictive values were calculated. Statistical analysis accounting for correlation between lesion-examinations and between-reader variability was performed using OR/DBM (for SAS v.3.0), generalized linear mixed model for binary data (proc glimmix, SAS v.9.4, SAS Institute, Cary North Carolina), and bootstrap. RESULTS: The cohort included 49 benign, two high-risk and nine cancerous lesions in 54 women aged 34-74 (average 50) years. Reader-averaged AUC for CEDM was significantly higher than DM/DBT alone (0.85 versus 0.66, p < 0.001) or with US (0.85 versus 0.75, p = 0.001). CEDM increased true positive rates from 0.74 under DB/DBT, and 0.89 with US, to 0.90 with CEDM, (p = 0.019 DM/DBT versus CEDM, p = 0.78 DM/DBT + US versus CEDM) and decreased false positive rates from 0.47 using DM/DBT and 0.61 with US to 0.39 with CEDM (p = 0.017 DM/DBT versus CEDM, p = 0.001 DM/DBT+ US versus CEDM). For an expected cancer rate of 10%, CEDM positive predictive values was 20.5% (95% CI: 16%-27%) and negative predictive values 98.3% (95% CI: 96%-100%). CONCLUSION: Addition of CEDM for evaluation of low-moderate suspicion soft tissue breast lesions can substantially reduce biopsy of benign lesions without compromising cancer detection.

A Prospective Study of Automated Breast Ultrasound Screening of Women with Dense Breasts in a Digital Breast Tomosynthesis-based Practice.

OBJECTIVE: To assess prospectively the interpretative performance of automated breast ultrasound (ABUS) as a supplemental screening after digital breast tomosynthesis (DBT) or as a standalone screening of women with dense breast tissue. METHODS: Under an IRB-approved protocol (written consent required), women with dense breasts prospectively underwent concurrent baseline DBT and ABUS screening. Examinations were independently evaluated, in opposite order, by two of seven Mammography Quality Standards Act-qualified radiologists, with the primary radiologist arbitrating disagreements and making clinical management recommendations. We report results for 1111 screening examinations (598 first year and 513 second year) for which all diagnostic workups are complete. Imaging was also retrospectively reviewed for all cancers. Statistical assessments used a 0.05 significance level and accounted for correlation between participants' examinations. RESULTS: Of 1111 women screened, primary radiologists initially "recalled" based on DBT alone (6.6%, 73/1111, CI: 5.2%-8.2%), of which 20 were biopsied, yielding 6/8 total cancers. Automated breast ultrasound increased recalls overall to 14.4% (160/1111, CI: 12.4%-16.6%), with 27 total biopsies, yielding 1 additional cancer. Double reading of DBT alone increased the recall rate to 10.7% (119/1111), with 21 biopsies, with no improvement in cancer detection. Double reading ABUS increased the recall rate to 15.2% (169/1111, CI: 13.2%-17.5%) of women, of whom 22 were biopsied, yielding the detection of 7 cancers, including one seen only on double reading ABUS. Inter-radiologist agreement was similar for recall recommendations from DBT (κ = 0.24, CI: 0.14-0.34) and ABUS (κ = 0.23, CI: 0.15-0.32). Integrated assessments from both readers resulted in a recall rate of 15.1% (168/1111, CI: 13.1%-17.4%). CONCLUSION: Supplemental or standalone ABUS screening detected cancers not seen on DBT, but substantially increased noncancer recall rates.

Multicenter evaluation of a new ultrasound-guided biopsy device: Improved ergonomics, sampling and rebiopsy rates.

The purpose of this study was to evaluate performance, ergonomics, and immediate rebiopsy rate of a new vacuum-assisted biopsy (VAB) device for ultrasound-guided breast biopsies. Between December 2002 and April 2003, 113 patients meeting study criteria were biopsied at four centers using the new 9 gauge VAB device. The device has a radiofrequency-tipped probe, 360 degrees vacuum, a circumferential cutter, and a coaxial cannula for multiple sampling. Patient and procedural data included breast composition, lesion characteristics, number of samples, procedure time, and complications. Quality of samples, lesion access, and ergonomic features were assessed qualitatively and compared with prior experience with other biopsy devices. Immediate rebiopsy rate included high-risk lesions requiring surgical excision (obligate rebiopsy) and lesions requiring rebiopsy due to discordance or insufficient samples yielding nondiagnostic material. Data were analyzed using the Wilcoxon signed-rank test. One hundred thirteen patients aged 20-83 years (mean 52) were successfully biopsied with dense/fibrous breast tissue in 60% and dense/fibrous lesions in 49%. Lesions measured 6-63 mm (mean 17); 97% were masses. Five circumferential specimens (range 2-19) were obtained in 6 minutes (range 2-20). Operators rated safety and comfort comparable with existing devices and rated sample quality, breast/lesion penetration, and positioning ease/accuracy superior (p < 0.01). Diagnoses included 37 cancers, 70 benign, and six high-risk lesions with one upgrade from atypical ductal hyperplasia to ductal carcinoma in situ at surgery. Excluding obligate excision in high-risk diagnoses, the immediate rebiopsy rate was 2%. No complications required intervention. The new VAB device provides diagnostic samples and reduces sampling error defined by immediate rebiopsy rate. Compared with other devices, it is more ergonomic to target and position for sampling, particularly in dense breast tissue or lesions.

Breast cyst recurrence after postaspiration injection of air.

Breast cysts are a common cause of breast pain, lumps, and patient anxiety. Older studies incidentally reported a decrease in cyst recurrence when air was injected for diagnostic purposes after aspiration. The purpose of this study was to determine the incidence of cyst recurrence after ultrasound-guided aspiration and injection of air for therapeutic purposes. In this study, we retrospectively reviewed 113 cysts aspirated in 90 women; 88 had air injected for therapeutic purposes after aspiration, and 25 did not. Subsequent mammograms and sonograms were reviewed (mean follow-up 21 months, range of 8-36 months) to assess for recurrence. Demographic and imaging features were not different between the two study groups. Of the 88 cysts that had air injected after aspiration, 14 recurred (16%) compared with 20 of 25 cysts (80%) that did not have air injected following aspiration. Cyst recurrence correlated with air injection, but did not correlate with cyst size, menopausal status, or use of hormone replacement therapy. Only one patient complained of pain, and no complications occurred. The injection of air into cysts following aspiration may be useful for therapeutic purposes.