1st author year [Ref], study name (if any), country | Inclusion criteria | Design/analysis | Participants | Round | Results | Comments |
---|---|---|---|---|---|---|
Bakker 2019 [27], DENSE, The Netherlands | Women aged 50−75 with negative mammography and ACR BI-RADS density d | Multicentre RCT: MRI vs mammography | 8061 in the MRI-invitation group (4783 accepted, 59%) 32,312 in the mammography-group | 1st | Interval cancer rate: 2.5‰ (MRI-group) vs 5.0‰ (mammography group) at intention-to-treat analysis; 0.8‰ (MRI group) vs 5.1‰ at complier average causal effect analysis | Supplemental MRI screening resulted in the diagnosis of significantly fewer interval cancers compared to mammography alone during a 2-year screening period. |
Comstock 2020 [97], EA1141 ECOG-ACRIN, USA, Germany | Women aged 40−75 scheduled to screening with DBT with ACR BI-RADS density c or d | Multicentre, intraindividual, comparative, cross-sectional study with longitudinal follow-up: abbreviated MRI vs DBT | 1444 women underwent both examinations | Invasive cancer detection rate: 11.8‰ (MRI) vs 4.8‰ (DBT) | Abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. | |
Veenhuizen 2021 [96], DENSE, The Netherlands | ACR BI-RADS density d who already underwent first round of screening with MRI in the DENSE trial | Multicentre RCT: MRI vs. mammography | 3436 women attending the second MRI screening, out of 4783 attending the first round | 2nd | Cancer detection rate: 5.8‰ (2nd round) vs 16.5‰ (1st round). False-positive rate: 26.3 ‰ (2nd round) vs 79.8‰ (1st round). All MRI-detected cancers in the 2nd round were early stage (0–I) and node negative. | The results of 2nd round play in favour of the MRI detection of prevalent cancers at 1st round, not detected by mammography. The availability of prior MRI examination can partly explain the reduction in the false-positive rate. |
den Dekker 2021 [98], DENSE, The Netherlands | Positive patients with MRI BI-RADS 3, 4, or 5 years at the first round in the DENSE trial | Multivariable logistic regression | 454 women recalled for diagnostic work-up | 1st | 79 true-positives and 375 false-positives. The prediction model based on all clinical characteristics and MRI findings could have prevented 46% of false-positive recalls and 21.3% of benign biopsies without missing any cancers. | Prediction models based on clinical characteristics and MRI findings may be useful to reduce the false-positives first-round screening MRI rate and benign biopsy rate in women with extremely dense breasts. |