Table 2.
Summary of Findings in Reviewed Literature.
| Study | Study Description | Method | No. of Screening US Exam | No. of US-Only Cancers | Mammography Plus Ultrasound | Additional Cancer Yield from US per 1000 Women Screened | ||
|---|---|---|---|---|---|---|---|---|
| Sensitivity (%) | Specificity (%) | Positive Predictive Value (%) | ||||||
| Kaplan [15] | BI-RADS c-d density; patients with negative clinical examination and mammographic findings; in patients with focal abnormal mammographic findings or palpable abnormalities, all areas of the breast outside of the quadrant with abnormalities were evaluated with ultrasound | Tech HHUS |
1862 | 6 | - | - | - | 3.2 |
| Kolb et al. [6] | BI-RADS b-d density; patients with no clinical symptoms | MD HHUS |
13,547 | 37 | 97.3 | - | - | 2.73 |
| Leconte et al. [16] | BI-RADS a-d density; palpable abnormalities were excluded from analysis | MD HHUS |
4236 | 16 | B1-2 density: MA = 80 US = 88 |
- | - | 3.8 |
| B3-4 density: MA = 56 US = 88 | ||||||||
| Berg et al. [17] | BI-RADS c-d density in at least one quadrant and at high risk; radiologist blinded to mammography and physical examination findings | MD HHUS |
2809 | 12 | 77.5 | - | 11.2 | 4.2 |
| Berg et al. [18] | BI-RADS c-d density in at least one quadrant and at high risk; radiologist blinded to mammography and physical examination findings | MD HHUS |
2809 | 32 | 76 | 84 | 16 | 3.7 |
| Hooley et al. [19] | BI-RADS c-d density; patients with no clinical symptoms; mammographic findings were excluded | Tech HHUS |
935 | 3 | - | - | 6.5 | 3.2 |
| Weigert and Steenberge [20] | BI-RADS c-d density; patients with normal mammograms; no clinical symptoms | Tech HHUS |
8647 | 28 | 96.6 | 94.9 | 6.7 | 3.25 |
| Weigert and Steenbergen [21] | BI-RADS c-d density; patients with normal mammograms; no clinical symptoms | Tech HHUS |
10,282 | 24 | - | 96 | 9 | 2.3 |
| Brem et al. [22] | BI-RADS c-d density; patients with normal mammograms and no clinical symptoms | Tech ABUS |
15,318 | 30 | 100 | 72 | 2.6 | 1.9 |
| Tagliafico et al. [23] | BI-RADS c-d density; patients with no clinical symptoms; mammography-negative; radiologist who performed ultrasound aware of negative 2D mammography and blinded to tomosynthesis | MD HHUS |
3231 | 11 (not seen on 2D or 3D) | - | - | - | 3.4 (not seen on 2D or 3D) |
| 23 (seen also on 3D) | 7.1 (seen also on 3D) | |||||||
| Ohuchi et al. [24] | BI-RADS a-d density; intervention group included mammography and ultrasound on all patients; control group included mammography only; radiologists blinded to mammography and ultrasound findings | Tech HHUS |
36,752 | 67 | - | - | - | 1.8 |
| Giger et al. [25] | BI-RADS c-d density; patients with no clinical symptoms; retrospective study design | Tech ABUS | 185 | 31 | 74.1 | 76.1 | - | |
| Wilczek et al. [26] | BI-RADS c-d density; patients with no clinical symptoms; first reader interpreted mammogram and ultrasound; second reader interpreted ultrasound only | Tech ABUS | 1668 | 4 | - | - | 33.3 | 2.4 |
| Weigert [27] | BI-RADS c-d density; patients with normal mammograms; no clinical symptoms; 4 year retrospective study design | Tech HHUS |
Year 1: 2706 | 11 | - | - | 7.3 | 4 |
| Year 2: 3351 | 9 | - | - | 5 | 2.7 | |||
| Year 3: 4128 | 11 | - | - | 7.4 | 2.7 | |||
| Year 4: 3331 | 10 | - | - | 18.9 | 3 | |||
| Destounis et al. [28] | BI-RADS c-d density; patients with no clinical symptoms | HHUS | 5434 | 18 | - | - | 18 | 3.3 |
Note—Dashes indicate parameter was not reported in cited article. US—Ultrasound, MD—Radiologist, HHUS—Handheld ultrasound, Tech—Technologist, MA—Mammography, ABUS—Automated whole breast ultrasound.