Introduction
Materials and methods
Study design
Data collection
Imaging protocol
PFB-CEUS
MP-MRI
Imaging analysis
Reference standard
Statistical analysis
Results
Participant and imaging characteristics
Characteristic | Overall lesions (n = 186) | Development cohort (n = 151) | Validation cohort (n = 35) |
---|---|---|---|
Age (years)b | 49 ± 11 (19, 76) | 49 ± 11 (19, 76) | 49 ± 10 (27, 68) |
Age (years)b | |||
< 49 | 90 (48.4) | 76 (50.3) | 14 (40.0) |
≧ 49 | 96 (51.6) | 75 (49.7) | 21 (60.0) |
Body mass index (kg/m2)b | 23.9 ± 3.5 (13.7, 37.0) | 23.9 ± 3.3 (16.4, 37.0) | 23.5 ± 4.2 (13.7, 34.1) |
Body mass index (kg/m2) | |||
< 18.5 | 6 (3.4) | 3 (2.1) | 3 (9.1) |
18.5 to < 25 | 110 (61.5) | 91 (62.3) | 19 (57.6) |
≥ 25.0 | 63 (35.2) | 52 (35.6) | 11 (33.3) |
Dense breaste | |||
Yes | 137 (76.5) | 107 (73.3) | 30 (90.9) |
No | 42 (23.5) | 39 (26.7) | 3 (9.1) |
Parity status | |||
Nulliparous | 16 (8.9) | 14 (9.6) | 2 (6.1) |
Parous | 163 (91.1) | 132 (90.4) | 31 (93.9) |
Menopausal statusc | |||
Premenopausal | 107 (59.8) | 89 (61.0) | 18 (54.5) |
Postmenopausal | 72 (40.2) | 57 (39.0) | 15 (45.5) |
First-degree relatives with breast cancerd | |||
Presence | 169 (94.4) | 138 (94.5) | 31 (93.9) |
Absence | 10 (5.6) | 8 (5.5) | 2 (6.1) |
Diagnosis method | |||
Surgery | 73 (39.2) | 62 (41.1) | 11 (31.4) |
Core biopsy | 113 (60.8) | 89 (58.9) | 24 (68.6) |
Lesion size (cm)a | 1.8 (1.2, 2.4) | 1.8 (1.2, 2.5) | 1.8 (1.3, 2.4) |
Lesion size (cm)a | |||
< 1.5 | 65 (34.9) | 52 (34.4) | 13 (37.1) |
≧ 1.5 | 121 (65.1) | 99 (65.6) | 22 (62.9) |
Histologic type | |||
Benign | 71 (38.1) | 58 (38.4) | 13 (37.1) |
Malignant | 115 (61.8) | 93 (61.6) | 22 (62.9) |
Model development and performance
Comparison among the three models
PFB-CEUS versus MP-MRI model
PFB-CEUS versus hybrid model
MP-MRI versus hybrid model
Model performance in subpopulations
Model performance for diagnosing breast cancer compared with radiologists
PFB-CEUS
BI-RADS (3 vs. 4a+) | BI-RADS (3, 4a vs. 4b+) | BI-RADS (3, 4a, 4b vs. 4c+) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Se% | P value | Sp% | P value | Se% | P value | Sp% | P value | Se% | P value | Sp% | P value | |
PFB-CEUS | ||||||||||||
On-sitea | 97.4 (112/115) | 56.3 (40/71) | 93.9 (108/115) | 78.9 (56/71) | 78.3 (90/115) | 91.5 (65/71) | ||||||
(92.6, 99.5) | (44.0, 68.1) | (87.9, 97.5) | (67.6, 87.7) | (69.6, 85.4) | (82.5, 96.8) | |||||||
Reviewersb | 94.8 (109/115) | 36.6 (26/71) | 86.1 (99/115) | 70.4 (50/71) | 78.3 (90/115) | 78.9 (56/71) | ||||||
(89.0, 98.1) | (25.5, 48.9) | (78.4, 91.8) | (58.4, 80.7) | (69.6, 85.4) | (67.6, 87.7) | |||||||
CEUS model | NA | –c | NA | –c | 97.4 (112/115) | 0.344c | 36.6 (26/71) | < 0.001c | 88.7 (102/115) | 0.029c | 80.3 (57/71) | 0.096c |
–d | –d | (92.6, 99.5) | 0.001d | (25.5, 48.9) | < 0.001d | (81.4, 93.8) | 0.023d | (69.1, 88.8) | –d | |||
Hybrid model | 100.0 (115/115) | –c | 25.4 (18/71) | < 0.001c | 100.0 (115/115) | –c | 50.7 (36/71) | 0.001c | 90.4 (104/115) | 0.004c | 84.5 (60/71) | 0.332c |
(96.8, 100.0) | –d | (15.8, 37.1) | 0.229d | (96.8,100.0) | –d | (38.6, 62.8) | 0.009d | (83.5, 95.1) | 0.004d | (74.0, 92.0) | 0.454d | |
MP-MRI | ||||||||||||
On-sitea | 98.3 (113/115) | 49.3 (35/71) | 92.2 (106/115) | 73.2 (52/71) | 80.0 (92/115) | 87.3 (62/71) | ||||||
(93.9, 99.8) | (37.2, 61.4) | (85.7, 96.4) | (61.4, 83.1) | (71.5, 86.9) | (77.3, 94.0) | |||||||
Reviewersb | 93.9 (108/115) | 25.4 (18/71) | 89.6 (103/115) | 46.5 (33/71) | 81.7 (94/115) | 67.6 (48/71) | ||||||
(87.9, 97.5) | (15.8, 37.1) | (82.5, 94.5) | (34.5, 58.7) | (73.5, 88.3) | (55.5, 78.2) | |||||||
MRI model | 100.0 (115/115) | –e | 11.3 (8/71) | < 0.001e | 98.3 (113/115) | 0.016e | 40.8 (29/71) | < 0.001e | 88.7 (102/115) | 0.041e | 80.3 (57/71) | 0.332e |
(96.8, 100.0) | –f | (5.0, 21.0) | 0.041f | (93.9, 99.8) | 0.006f | (29.3,53.2) | 0.627f | (81.4, 93.8) | 0.134f | (69.1, 88.8) | 0.078f | |
Hybrid model | 100.0 (115/115) | –e | 25.4 (18/71) | 0.002e | 100.0 (115/115) | –e | 50.7 (36/71) | 0.004e | 90.4 (104/115) | 0.017e | 84.5 (60/71) | 0.815e |
(96.8, 100.0) | –f | (15.8, 37.1) | –f | (96.8, 100.0) | –f | (38.6, 62.8) | 0.711f | (83.5, 95.1) | 0.052f | (74.0, 92.0) | 0.023f |