Table 1.
Results of studies examining screening ultrasound as an adjunct to mammography in women with dense breasts
| Author, Year | Number of women with Cancer a |
Number of Women Screened |
CDR per 1000 |
Net Added Recalls due to US (% of Screens) |
Biopsy Rate (%)b |
PPV3 of biopsies prompted only by US (%)c |
N Invasive, grade |
Mean size (mm, range) |
Node Negative (%) |
DCIS (% of cancers), grade |
BI-RADS 3 | Commentsd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single-center | ||||||||||||
| Gordon, 1995 | 30 | 12706 | 2.4 | NR | NR | 44/279 (16) | 44, no details about grade |
11 (4–25) | NR | 0 | NR | Diagnostic population |
| Buchberger, 2000 |
40e | 8970 | 4.5 | NR | NR | 40/405 (9.9) | 35, no details about grade |
9.1 (4–20) | 33/35 (94.3) | 5 (12.5), no details about grade |
NR | 8103 women in a screening population and 867 in a diagnostic population |
| Kaplan, 2001 | 5 | 1862 | 3.2 | 176 (9.5) | 97 (5.2) | 6/96 (6.3) | 5, no details about grade |
9 (6–14) | 5/5 (100) | 1 (16.7), no details about grade |
NR | Technologist performed |
| Kolb, 2002 | 34 | 5418 women, 13547 screens |
2.7 | 799 (5.9) | NR | 37/358 (10) | 36, no details about grade |
9.9 (range: NR) | 25/28 (89.3)f | 1 (2.7) , no details about grade |
NR | 1,354 exams in women with abnormal mammogram or CBE |
| Crystal, 2003 | 7 | 1517 | 4.6 | 90 (5.9) | 38 (2.5) | 7/38 (18) | 7; 1 low, 1 intermediate, 4 high-grade and 1 lobular |
9.6 (4–12) | 6/7 (85.7) | 0 | NR | |
| Leconte, 2003 | 16 | 4236 | 3.8 | NR | NR | NR | 14, no details about grade |
7 (4–17) | NR | 2 (12.5), no details about grade |
NR | Included 136 women with palpable mass |
| Brancato, 2007 | 2 | 5227 | 0.4 | NR | 65 (1.2) | 2/65 (3.1) | 2, no details about grade |
NR | 2/2 (100) | 0 | NR | Mammography-negative women |
| De Felice, 2007 | 12 | 1754 | 6.8 | NR | 46 (2.6) | NR | 10, no details about grade |
10 (5–15) | 10/10 (100) | 2 (16.7), no details about grade |
NR | |
| Youk, 2011 | 17 | 1418 | 12.0 | 200 | 80 (5.6) | 17/80 (21.3) | NRg | 13 (6–20) | NRg | NRg | NR | Mammography-negative women, retrospective database review, general screening and personal history of breast cancer subsets |
| Hooley, 2012 | 3 | 935 | 3.2 | 234 (25.0) | 53 (5.7) | 3/63 (4.8) | 2, no details about grade |
6.3 (5–9) | 2/2 (100) | 1 (33.3), no details about grade |
187 (20.0) | Technologist performed |
| Girardi, 2013 | 41 | 22,131 | 1.9 | NR | 422 (1.9) | 41/422 (9.7) | 37, no details about grade |
8 (5–12) | 36/37 (97.3) | 4 (9.8) , no details about grade |
NR | Mammography-negative women |
| Bae, 2014 | 329 | 106829 women, 116656 screens |
3.1 | NR | NR | NR | 282, no details about grade |
NRi | 253/282 (89.7) |
53 (15.8) no details about grade |
NR | Retrospective database review |
| Korpraphong, 2014 |
19 | 14483 screens |
1.4 | NR | NR | NR | NR | NR | NR | NR | NR | |
| Wilczek, 2016 | 4 | 1668 | 2.4 | 15 (0.9) | 12 (0.7) | NR | 4 (2 low-, 1 intermediate, 1 high-grade) |
21.8 (13–40) | 2/4 (50) | 0 | NR | ABUS, technologist performed |
| Destounis, 2017 |
18 | 4898 women, 5434 screens |
3.3 | NR | 100 (2.0) | 18/100 (18.0) | 18 (5 low-, 7 intermediate-, 4 high-grade and 2 not specified) |
1–5 mm: 1 case; 6– 10 mm: 7 cases; 11–15 mm: 4 cases; 16–20 mm: 1 case; >20 mm: 4 case; not specified: 1 case |
14/18 (78.0) | 0 | 101 (1.9)j | Retrospective review |
| Kim, 2017 | 8 | 778 | 10.3 | NR | NR | NR | 5 | 26.3 (1–70) | 4/5 (80) | 3 (37.5) | NR | |
| Multicenter | ||||||||||||
| Corsetti, 2008 | 37e | 9157 | 4 | NR | 449 (4.9) | 50/449 (11.1)k | 36, no details about grade |
NRl | 31/36 (86.1) | 1 (2.7), no details about grade |
NR | Self-referred women; 13/50 cancers excluded (palpable or symptoms) |
| Kelly, 2010 | 23e | 4419 women, 6425 screens |
3.6 | 557 (8.7) | 75 (1.2) | 23/75 (30.7) | 22 (7 low, 13 intermediate, 2 high) |
5 mm or less: 1 case; 6–10 mm: 13 cases; 11–20 mm: 6 cases; 21–50 mm: 1 case; >50 mm: 1 case |
NR | 1 (4.3), no details about grade |
NR | Automated arm, technologist acquired |
| Berg, 2012, prevalence |
14 | 2659 | 5.3 | 401 (15.1) | 207 (7.8) | 12/207 (5.8) | 30 (11 low, 7 intermediate, 6 high, 5 lobular and 1 mixed ductal- lobular) |
10 (median; range: 2–40) |
29/30 (96.7) | 2 (6.25) (1 intermediate- and 1 high- grade) |
NR | 1st screen; at least 1 other risk factor, 20% were high-risk women; ≥ BI-RADS 3 = positive. |
| Berg, 2012, incidence |
18 | 4841 screens |
3.7 | 356 (7.4) | 242 (5.0) | 18/242 (7.4) | Year 2, 3 screens; 612 women had MR screen after year 3 US screen |
|||||
| Weigert, 2017, prevalence |
11 | 2706 | 4.1 | 325 (12.0) | 151 (5.6) | 11/151 (7.3) | 9 (1 low, 6 intermediate, 2 high) |
25 (12–80) | 7/9 (77.8) | 2 (18.2), all intermediate grade |
NR | Technologist performed, BI-RADS 3 or higher considered recall as presented |
| Weigert, 2017, Incidencem |
30 | 10810 | 2.8 | 1073 (9.9) | 379 (3.5) | 30/379 (7.9) | 25 (3 low, 17 intermediate, 5 high grade) |
10.9 (4–30) | 20/25 (80.0) | 5 (16.7) (4 intermediate, 1 high grade) |
NR | Technologist performed, BI-RADS 3 or higher considered recall as presented |
| Brem, 2015 | 30 | 15318 | 2.0 | 2063 (13.5) | 551 (3.6) | 30/551 (5.4) | 28, no details about grade |
12.9 | 25/27 (92.6) | 2 (6.7), no details about grade |
19 (0.1) | ABUS, technologist performed |
| Ohuchi, 2016 | 67 | 36752 | 1.8 | 1932 (5.25) | NR | NR | 55, no details about grade |
14.2 | 47/55 (85.5) | 11 (16.7), no details about grade |
NR | Women aged 40–49 with any breast density |
| Buchberger, 2018 |
36 | 66680 | 0.5 | 397 (0.60) | 201 (0.30) |
36/201 (17.9) | 33, no details about grade |
14 (median; 3–32) | 25/33 (75.8) | 3 (8.3), no details about grade |
1255 (1.9) | Population-based observational study in Tyrol, Austria ages 40–69, all breast densities |
Number or women found to have cancer on screening ultrasound
Percent of women who underwent biopsy due to screening US
Percent of lesions biopsied due to screening US that were malignant
Studies utilized physician (radiologist) performed handheld screening ultrasound unless otherwise specified
These studies referred to numbers of cancers (and not to the number of women)
Kolb et al. provided this information for 28 of 36 invasive cancers
Youk et al, provided data about 8 of 10 cancers diagnosed in the general screening arm (7 of 8 were DCIS or stage 1; one of eight was node positive)
Bae et al did not report mean tumor size or range but 176/335 (53%) were minimal cancers and 52 (16%) were stage II
Destounis et al. provided this as a fraction of screens
13 of these women were found to have symptoms and were excluded from “US-screen-detected” cancers
Corsetti et al. did not provide the mean tumor size or range but 3/36 were stage T1a, 20/36 T1b, 10/36 T1c, 2/36 T2 and 1/36 stage T3
In year 4 of Weigert et al, of 3331 US, 53 recommended biopsies, 10 cancers, 358 BI-RADS 3. Higher PPV3 but v. high BI-RADS 3 rate.
ABUS: Automated Breast Ultrasound System; CDR: Cancer Detection Rate; NR: Not Reported; PPV: Positive Predictive Value; US: Ultrasonography