Combined Screening With Ultrasound and Mammography vs Mammography Alone in Women With Elevated Risk of Breast Cancer (vol 299, pg 2151, 2008)

American Radiology Services Inc, Johns Hopkins Green Spring, Lutherville, Maryland, USA.
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 06/2008; 299(18):2151-63. DOI: 10.1001/jama.299.18.2151
Source: PubMed

ABSTRACT Screening ultrasound may depict small, node-negative breast cancers not seen on mammography.
To compare the diagnostic yield, defined as the proportion of women with positive screen test results and positive reference standard, and performance of screening with ultrasound plus mammography vs mammography alone in women at elevated risk of breast cancer.
From April 2004 to February 2006, 2809 women, with at least heterogeneously dense breast tissue in at least 1 quadrant, were recruited from 21 sites to undergo mammographic and physician-performed ultrasonographic examinations in randomized order by a radiologist masked to the other examination results. Reference standard was defined as a combination of pathology and 12-month follow-up and was available for 2637 (96.8%) of the 2725 eligible participants.
Diagnostic yield, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) of combined mammography plus ultrasound vs mammography alone and the positive predictive value of biopsy recommendations for mammography plus ultrasound vs mammography alone.
Forty participants (41 breasts) were diagnosed with cancer: 8 suspicious on both ultrasound and mammography, 12 on ultrasound alone, 12 on mammography alone, and 8 participants (9 breasts) on neither. The diagnostic yield for mammography was 7.6 per 1000 women screened (20 of 2637) and increased to 11.8 per 1000 (31 of 2637) for combined mammography plus ultrasound; the supplemental yield was 4.2 per 1000 women screened (95% confidence interval [CI], 1.1-7.2 per 1000; P = .003 that supplemental yield is 0). The diagnostic accuracy for mammography was 0.78 (95% CI, 0.67-0.87) and increased to 0.91 (95% CI, 0.84-0.96) for mammography plus ultrasound (P = .003 that difference is 0). Of 12 supplemental cancers detected by ultrasound alone, 11 (92%) were invasive with a median size of 10 mm (range, 5-40 mm; mean [SE], 12.6 [3.0] mm) and 8 of the 9 lesions (89%) reported had negative nodes. The positive predictive value of biopsy recommendation after full diagnostic workup was 19 of 84 for mammography (22.6%; 95% CI, 14.2%-33%), 21 of 235 for ultrasound (8.9%, 95% CI, 5.6%-13.3%), and 31 of 276 for combined mammography plus ultrasound (11.2%; 95% CI. 7.8%-15.6%).
Adding a single screening ultrasound to mammography will yield an additional 1.1 to 7.2 cancers per 1000 high-risk women, but it will also substantially increase the number of false positives. Identifier: NCT00072501.

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Available from: Richard G Barr, Sep 25, 2015
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    • "Almost 50% of women under the age of 50 have dense breasts [5] and could be potentially deemed undiagnosed after mammography screening [6], [7]. Ultrasound, along with mammography, has been proven to improve the sensitivity in palpable breast masses [4], [8], [9], but due to its low sensitivity towards nonpalpable and noncystic breast lesions, it is not used as a primary screening modality. Ultrasound is now widely used for supplementary screening in women with dense breasts, both by hand-held and automated modalities. "
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    • "high rates of both false-negative and false-positive results (Berg et al. 2008, 2012; Gartlehner et al. 2013; Kolb et al. 2002; Sehgal et al. 2006; Teh and Wilson 1998). MRI is expensive and not widely available to all patients. "
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    ABSTRACT: We previously investigated the application of a novel imaging modality, vibro-acoustography (VA), using an annular confocal transducer (confocal VA) integrated into a clinical prone stereotactic mammography system, to detect various breast abnormalities. To shorten the scanning time and provide improved coverage of the breast, we have evolved our imaging system by implementing VA on a clinical ultrasound scanner equipped with a “quasi-2-D” array transducer. We call this technique “quasi-2-D vibro-acoustography” (Q2-DVA). A clinical ultrasound scanner (GE Vivid 7) was modified to perform both ultrasound imaging and VA using an array transducer consisting of a matrix of 12 rows by 70 columns of ultrasound elements. The newly designed system was used to perform VA on patients with either benign or cancerous lesions. Our results indicate that benign and malignant solid breast lesions were easily detected using our newly modified VA system. It was also possible to detect microcalcifications within the breast. Our results suggest that with further development, Q2-DVA could provide high-resolution diagnostic information in the clinical setting and may be used either as a stand-alone or as a complementary tool in support of other clinical imaging modalities.
    Ultrasound in Medicine & Biology 08/2014; 40(12). DOI:10.1016/j.ultrasmedbio.2014.07.005 · 2.21 Impact Factor
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    • "One of the main barriers to the implementation of supplemental screening ultrasonography is its high false positive findings of BIRADS category 3 or 4 lesions, leading to benign biopsy results [21]. Recent prospective studies regarding screening ultrasonography reported that approximately 20% (187 of 935, 519 of 2,662) of patients had BI-RADS category 3 lesions in the Connecticut study and also in the ACRIN 6666 study [7,8]. "
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    ABSTRACT: Purpose: To evaluate the negative predictive value (NPV) of ultrasound (US) elastography for non-palpable Breast Imaging Reporting and Data System (BI-RADS) category 3 lesions on ultrasonography and to determine whether US elastography is helpful in reducing the number of BI-RADS category 3 lesions on ultrasonography. Methods: Two hundred seventy-six consecutive, non-palpable BI-RADS category 3 lesions in 256 women who underwent US elastography and US-guided core biopsy, and who had at least 12 months of follow-up data, comprised our study group. The BI-RADS final assessment category and elasticity score were prospectively and independently classified. The rate of malignancy and NPV according to the elasticity score were analysed. We also investigated whether there was a subset of BI-RADS category 3 lesions that were of benign histology but negative on elastography. Results: Of the 276 non-palpable BI-RADS category 3 lesions, three lesions (1.0%) were finally confirmed as ductal carcinomas in situ. No cancers were found in the remaining 273 lesions with benign biopsy histology at a mean follow-up of 39.4 months (range, 12 to 72 months). The NPV of a negative elasticity score (elasticity score of 1) was 99.3% (165 of 166). If BI-RADS category 3 lesions showing a negative elasticity score were downgraded to BI-RADS category 2, 60.4% (165 of 273) of them with benign histology could have been safely followed without biopsy with an increased malignancy rate from 1% (3 of 276) to 1.8% (2 of 110), which is not significantly higher (P=0.626). Conclusion: US elastography has the potential to reduce the number of BI-RADS category 3 lesions on ultrasonography.
    04/2014; 33(2):98-104. DOI:10.14366/usg.13024
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