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Randomized Controlled Trial
. 2016 Jan;26(1):184-90.
doi: 10.1007/s00330-015-3803-3. Epub 2015 May 1.

Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmö Breast Tomosynthesis Screening Trial, a population-based study

Affiliations
Randomized Controlled Trial

Performance of one-view breast tomosynthesis as a stand-alone breast cancer screening modality: results from the Malmö Breast Tomosynthesis Screening Trial, a population-based study

Kristina Lång et al. Eur Radiol. 2016 Jan.

Abstract

Objective: To assess the performance of one-view digital breast tomosynthesis (DBT) in breast cancer screening.

Methods: The Malmö Breast Tomosynthesis Screening Trial is a prospective population-based one-arm study with a planned inclusion of 15000 participants; a random sample of women aged 40-74 years eligible for the screening programme. This is an explorative analysis of the first half of the study population (n = 7500). Participants underwent one-view DBT and two-view digital mammography (DM), with independent double reading and scoring. Primary outcome measures were detection rate, recall rate and positive predictive value (PPV). McNemar's test with 95 % confidence intervals was used.

Results: Breast cancer was found in sixty-eight women. Of these, 46 cases were detected by both modalities, 21 by DBT alone and one by DM alone. The detection rate for one-view DBT was 8.9/1000 screens (95 % CI 6.9 to 11.3) and 6.3/1000 screens (4.6 to 8.3) for two-view DM (p < 0.0001). The recall rate after arbitration was 3.8 % (3.3 to 4.2) for DBT and 2.6 % (2.3 to 3.0) for DM (p < 0.0001). The PPV was 24 % for both DBT and DM.

Conclusion: Our results suggest that one-view DBT might be feasible as a stand-alone screening modality.

Key points: One-view DBT as a stand-alone breast cancer screening modality has not been investigated. One-view DBT increased the cancer detection rate significantly. The recall rate increased significantly but was still low. Breast cancer screening with one-view DBT as a stand-alone modality seems feasible.

Keywords: Breast Cancer; Diagnostic Imaging; Mammography; Screening; Women’ Health.

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Figures

Fig. 1
Fig. 1
Reading procedure flowchart. Blinded double reading and scoring in independent reading arms. Each step was scored before proceeding to the next step. A positive score (3–5) in any step qualified the case for arbitration. Prior DM was a two-view DM. DBT = digital breast tomosynthesis, DM = digital mammography, MLO = mediolateral oblique view, CC = craniocaudal view
Fig. 2
Fig. 2
Study population flow chart. DBT = digital breast tomosynthesis, DM = digital mammography
Fig. 3
Fig. 3
Cancer detected by digital breast tomosynthesis alone. A sixty-six-year-old asymptomatic woman recalled for findings suspected only on digital breast tomosynthesis. A 15-mm invasive ductal carcinoma, histological grade 1 and lymph node negative, was diagnosed at histological examination

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