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2.  Detection of Breast Cancer with Addition of Annual Screening Ultrasound or a Single Screening MRI to Mammography in Women with Elevated Breast Cancer Risk 
Context
Annual ultrasound (US) may detect small, node-negative breast cancers not seen on mammography (M). MRI may depict additional breast cancers beyond mammography and ultrasound (M+US).
Objective
Determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer.
Design, Setting, Participants
From April 2004 to February 2006, 2809 women at 21 sites with elevated cancer risk and dense breasts consented to three annual independent screens with mammography and ultrasound in randomized order. After 3 rounds of mammography and US screening, 703 women from 14 sites consented to a single MRI.
Main Outcome Measures
Cancer detection rate (yield), sensitivity, specificity, positive predictive value of biopsies performed (PPV3 – rate of malignancy among cases positive on screening, who actually underwent biopsy), interval cancer rate. The diagnosis of breast cancer was based on a biopsy showing in situ or infiltrating ductal carcinoma or infiltrating lobular carcinoma in the breast or axillary lymph nodes. Reference standard was defined as a combination of pathology and 12-month follow-up and was available for 2662 women (7473 M+US screens) and 612 MRI participants.
Results
The 2662 patients underwent 7473 mammograms and US, with 110 women having 111 breast cancers detected, of which 33 were detected on mammography only, 32 on US only, 26 on both mammography and US, and 9 on MRI after mammography and US. Eleven were not detected by any imaging modality. Supplemental incidence-screening US identified 3.7 cancers per 1000 women-screens (95% CI 2.1 to 5.8, p<.001). Sensitivity, specificity, and PPV3 for M +US were 57/75 (0.76, 95% CI 0.65 to 0.85), 3987/4739 (0.84, 95% CI 0.83 to 0.85), and 55/339 (0.16, 95% CI 0.12 to 0.21); and for mammography alone 39/75 (0.52, 95% CI 0.40 to 0.64), 4325/4739 (0.91,95% 0.90 to 0.92), and 37/97 (0.38, 95% CI 0.28 to 0.49) (p<.001 all comparisons). Of 612 analyzable MRI participants, 16 (2.6%) had breast cancer diagnosed. Supplemental yield of MRI was 14.7 per 1000 (95% CI 3.5 to 25.9, p=.004). Sensitivity, specificity, and PPV3 for MRI+M+US were 16/16 (1.00, 95% CI 0.79 to 1.00), 390/596 (0.65, 95% CI 0.61 to 0.69), and 15/81 (0.19, 95% CI 0.11 to 0.29); and for M+US 7/16 (0.44, 95% CI 0.20 to 0.70, p=.004), 503/596 (0.84, 95% CI 0.81 to 0.87, p <.001), and 7/38 (0.18, 95% CI 0.08 to 0.34, p= .98) for M+US. Number of screens needed to detect one cancer was 127(95%CI 99 to 167) for mammography; 234(95%CI 173 to 345) for supplemental ultrasound, and 68 (95%CI 39 to 286) for MRI after negative M+US.
Conclusions
The addition of screening ultrasound or MRI to mammography in women at increased risk of breast cancer resulted in a higher cancer detection yield but also an increase in false positive findings.
doi:10.1001/jama.2012.388
PMCID: PMC3891886  PMID: 22474203
3.  Evaluation of Tissue Sampling Methods Used for MRI-Detected Contralateral Breast Lesions in the American College of Radiology Imaging Network 6667 Trial 
AJR. American journal of roentgenology  2012;199(3):W386-W391.
OBJECTIVE
The purpose of our study was to evaluate tissue sampling methods used for MRI-detected suspicious contralateral breast lesions in the American College of Radiology Imaging Network (ACRIN) 6667 trial.
MATERIALS AND METHODS
Breast MRI was performed at 25 institutions in 969 women who had a recent diagnosis of unilateral breast cancer and negative contralateral mammography and clinical breast examinations. Biopsy was recommended for MRI findings in 135 women, and 121 underwent sampling. Frequencies and positive biopsy rates of sampling methods used for initial diagnosis and imaging guidance techniques were calculated and compared.
RESULTS
Sampling yielded 30 malignant and 91 benign results. Initial sampling used needle biopsy in 88 of 121 (72.7%) and surgical biopsy in 30 of 121 (24.8%) women. Surgical biopsy was excisional biopsy in 28 of 30 (93.3%) and mastectomy in two of 30 (6.7%). The remaining three of 121 (2.5%) women underwent mastectomy, but it was not documented whether this represented initial tissue sampling. Of imaging-guided procedures, 56 of 106 (52.8%) used MRI; 49 of 106 (46.2%), ultrasound; and one of 106 (1.0%), stereotaxis. MRI-guided sampling was with needle biopsy rather than wire-localized surgical biopsy in 33 of 56 (58.9%) women, whereas ultrasound used needle biopsy in 47 of 49 (95.9%). Positive biopsy rates of sampling methods were 20.5% for needle biopsy, 46.2% for excisional biopsy, and 0% for mastectomy.
CONCLUSION
The majority of initial biopsies for MRI-detected contralateral breast lesions used needle biopsy rather than surgical biopsy. Contralateral surgery could have been avoided in most cases had needle biopsy been performed because most excisional biopsy and all mastectomy results were benign. MRI-guided biopsy was significantly more likely than ultrasound-guided sampling to use wire-localized surgical biopsy rather than needle biopsy.
doi:10.2214/AJR.11.7000
PMCID: PMC3703204  PMID: 22915431
breast MRI; contralateral breast lesions; tissue sampling methods
4.  False Positive Marks on Unsuspicious Screening Mammography with Computer-Aided Detection 
Journal of Digital Imaging  2011;24(5):772-777.
The contribution of computer-aided detection (CAD) systems as an interpretive aid in screening mammography can be hampered by a high rate of false positive detections. Specificity, false positive rate, and ease of dismissing false positive marks from two CAD systems are retrospectively evaluated. One hundred screening mammographic studies with a BI-RADS assessment code of 1 or 2 and at least 2-year normal mammographic follow-up were retrospectively reviewed using two CAD systems. Breast density, CAD marks, and radiologist's ease of dismissing false positive marks were recorded. Specificities from the two CAD versions considering all marks were 23% and 15% (p value = 0.07); mass marks, 35% and 17% (p value < 0.01); and calcification marks 62% and 75% (p value = 0.01). The two CAD versions did not differ regarding mean and median marks per case for all marks (2.3, 2.0 and 2.3, 2.0, p value = 0.65) or mass marks (1.6, 1.0 and 1.8, 2.0, p value = 0.15), but differed for calcification marks (0.8, 0 and 0.5, 0, p value < 0.01). Slightly higher specificity and fewer marks per case observed in dense breasts did not reach statistical significance. The reviewing radiologist classified most marks from both CAD systems (84% and 88%) as very easy/easy to dismiss. The two CAD versions had small differences in specificity and false positive marks. Differences, although not statistically significant, in specificities and false positive rates between dense and non-dense breasts warrant further research. Most false positive marks are easily dismissed and should not affect clinical performance.
doi:10.1007/s10278-011-9389-7
PMCID: PMC3180536  PMID: 21547517
Screening mammograms; Computer-aided detection (CAD); False positive marks; Specificity; Breast density
5.  Combined Screening with Ultrasound and Mammography Compared to Mammography Alone in Women at Elevated Risk of Breast Cancer: Results of the First-Year Screen in ACRIN 6666 
Context
Screening ultrasound (US) may depict small, node-negative breast cancers not seen on mammography (M).
Objective
To compare the diagnostic yield (proportion of women with a positive screen test and positive reference standard) and performance of screening with US+M compared to M alone in women at elevated risk of breast cancer.
Design, Setting, and Participants
From April 2004 to February 2006, 2809 women at elevated risk for breast cancer, with at least heterogeneously dense breast tissue in at least one quadrant, were recruited from 21 IRB-approved sites to undergo mammography (M) and physician-performed ultrasound (US) exams in randomized order by a radiologist masked to the results of the other exam. Reference standard was defined as a combination of pathology and 12 month follow-up, and was available for 2637 out of the 2725 eligible participants.
Main Outcome Measure
Diagnostic yield, sensitivity, specificity, and AUC of combined M+US compared to M alone; PPV of biopsy recommendations for M+US compared to M alone.
Results
Forty participants (41 breasts) were diagnosed with cancer: 8 suspicious on both US and M, 12 on US alone, 12 on M alone, and 8 participants (9 breasts) on neither (interval cancers). The diagnostic yield for M was 7.6 per 1000 women screened (20/2637) and increased to 11.8 per 1000 (31/2637) for combined US+M; the supplemental yield was 4.2 per 1000 women screened (95% CI 1.1 to 7.2 per 1000; p = 0.003 that the supplemental yield is zero). The diagnostic accuracy (AUC) for M was 0.78 (95% CI 0.67 to 0.87) and increased to 0.91 (95% CI 0.84 to 0.96) for US+M (p = 0.003 that difference is zero). Of 12 supplemental cancers seen only by US, 11 (92%) were invasive with median size 10 mm (range 5 to 40 mm; mean 12.6, SE 3.0) and 8/9 (89%) reported had negative nodes. PPV of biopsy recommendation after full diagnostic workup (PPV2) was 84/276 for M (22.6%, 95% CI 14.2 to 33%), 21/235 for US (8.9%, 95% CI 5.6 to 13.3%), and 31/276 for combined US+M (11.2%, 95% CI 7.8 to 15.6%).
Conclusions
Adding a single screening US to M will yield an additional 1.1 to 7.2 cancers per 1000 high-risk women, but will also substantially increase the number of false positives. Evaluation of the role of annual screening US is ongoing in this patient population. [Clinicaltrials.gov registry # NCT00072501]
doi:10.1001/jama.299.18.2151
PMCID: PMC2718688  PMID: 18477782

Results 1-5 (5)