Abstract
ObjectivesTo describe a randomized controlled trial (RCT) of digital breast tomosynthesis including synthesized two-dimensional mammograms (DBT) versus digital mammography (DM) in a population-based screening program for breast cancer and to compare selected secondary screening outcomes for the two techniques.MethodsThis RCT, performed in Bergen as part of BreastScreen Norway, was approved by the Regional Committees for Medical Health Research Ethics. All screening attendees in Bergen were invited to participate, of which 89% (14,274/15,976) concented during the first year, and were randomized to DBT (n = 7155) or DM (n = 7119). Secondary screening outcomes were stratified by mammographic density and compared using two-sample t-tests, chi-square tests, ANOVA, negative binomial regression and tests of proportions (z tests).ResultsMean reading time was 1 min 11 s for DBT and 41 s for DM (p < 0.01). Mean time spent at consensus was 3 min 12 s for DBT and 2 min 12 s for DM (p < 0.01), while the rate of cases discussed at consensus was 6.4% and 7.4%, respectively for DBT and DM (p = 0.03). The recall rate was 3.0% for DBT and 3.6% for DM (p = 0.03). For women with non-dense breasts, recall rate was 2.2% for DBT versus 3.4% for DM (p = 0.04). The rate did not differ for women with dense breasts (3.6% for both). Mean glandular dose per examination was 2.96 mGy for DBT and 2.95 mGy for DM (p = 0.433).ConclusionsInterim analysis of a screening RCT showed that DBT took longer to read than DM, but had significantly lower recall rate than DM. We found no differences in radiation dose between the two techniques.Key Points• In this RCT, DBT was associated with longer interpretation time than DM• Recall rates were lower for DBT than for DM• Mean glandular radiation dose did not differ between DBT and DM
Highlights
Digital breast tomosynthesis (DBT) in combination with digital mammography (DM) has been claimed to be superior to DM alone in prospective studies of cancer detection in European breast cancer screening programs [1,2,3,4]
In the first year of this randomized controlled trial (RCT) using DBT and DM in populationbased breast cancer screening, we found lower consensus and recall rates among women screened with DBT than with DM
Our density-stratified analyses identified that recall rates were lower for DBT only for women with non-dense breasts (VDG 1 and Volpara density grade (VDG) 2)
Summary
Digital breast tomosynthesis (DBT) in combination with digital mammography (DM) has been claimed to be superior to DM alone in prospective studies of cancer detection in European breast cancer screening programs [1,2,3,4]. A limited number of studies using DBT for screening have reported complete data on interval breast cancers [5,6,7], and there is presently limited knowledge about the characteristics of the cancers detected with DBT versus DM [5, 7,8,9]. Replacing the DM in DBT + DM with synthetic mammograms (SM), a 2D mammographic image reconstructed from the projection data obtained during the DBT acquisition, has been suggested as a solution and has recently shown promising results with respect to early performance measures in European screening programs [3, 8, 9, 13]. The sensitivity of DBT among women with dense breasts has been questioned [14,15,16]
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