Prospective trial comparing full-field digital mammography (FFDM) versus combined FFDM and tomosynthesis in a population-based screening programme using independent double reading with arbitration.

OBJECTIVES: To compare double readings when interpreting full field digital mammography (2D) and tomosynthesis (3D) during mammographic screening. METHODS: A prospective, Ethical Committee approved screening study is underway. During the first year 12,621 consenting women underwent both 2D and 3D imaging. Each examination was independently interpreted by four radiologists under four reading modes: Arm A-2D; Arm B-2D + CAD; Arm C-2D + 3D; Arm D-synthesised 2D + 3D. Examinations with a positive score by at least one reader were discussed at an arbitration meeting before a final management decision. Paired double reading of 2D (Arm A + B) and 2D + 3D (Arm C + D) were analysed. Performance measures were compared using generalised linear mixed models, accounting for inter-reader performance heterogeneity (P < 0.05). RESULTS: Pre-arbitration false-positive scores were 10.3 % (1,286/12,501) and 8.5 % (1,057/12,501) for 2D and 2D + 3D, respectively (P < 0.001). Recall rates were 2.9 % (365/12,621) and 3.7 % (463/12,621), respectively (P = 0.005). Cancer detection was 7.1 (90/12,621) and 9.4 (119/12,621) per 1,000 examinations, respectively (30 % increase, P < 0.001); positive predictive values (detected cancer patients per 100 recalls) were 24.7 % and 25.5 %, respectively (P = 0.97). Using 2D + 3D, double-reading radiologists detected 27 additional invasive cancers (P < 0.001). CONCLUSION: Double reading of 2D + 3D significantly improves the cancer detection rate in mammography screening. KEY POINTS: • Tomosynthesis-based screening was successfully implemented in a large prospective screening trial. • Double reading of tomosynthesis-based examinations significantly reduced false-positive interpretations. • Double reading of tomosynthesis significantly increased the detection of invasive cancers.

Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program.

PURPOSE: To assess cancer detection rates, false-positive rates before arbitration, positive predictive values for women recalled after arbitration, and the type of cancers detected with use of digital mammography alone and combined with tomosynthesis in a large prospective screening trial. MATERIALS AND METHODS: A prospective, reader- and modality-balanced screening study of participants undergoing combined mammography plus tomosynthesis, the results of which were read independently by four different radiologists, is under way. The study was approved by a regional ethics committee, and all participants provided written informed consent. The authors performed a preplanned interim analysis of results from 12,631 examinations interpreted by using mammography alone and mammography plus tomosynthesis from November 22, 2010, to December 31, 2011. Analyses were based on marginal log-linear models for binary data, accounting for correlated interpretations and adjusting for reader-specific performance levels by using a two-sided significance level of .0294. RESULTS: Detection rates, including those for invasive and in situ cancers, were 6.1 per 1000 examinations for mammography alone and 8.0 per 1000 examinations for mammography plus tomosynthesis (27% increase, adjusted for reader; P = .001). False-positive rates before arbitration were 61.1 per 1000 examinations with mammography alone and 53.1 per 1000 examinations with mammography plus tomosynthesis (15% decrease, adjusted for reader; P < .001). After arbitration, positive predictive values for recalled patients with cancers verified later were comparable (29.1% and 28.5%, respectively, with mammography alone and mammography plus tomosynthesis; P = .72). Twenty-five additional invasive cancers were detected with mammography plus tomosynthesis (40% increase, adjusted for reader; P < .001). The mean interpretation time was 45 seconds for mammography alone and 91 seconds for mammography plus tomosynthesis (P < .001). CONCLUSION: The use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Clinical trial registration no. NCT01248546.

Digital breast tomosynthesis (DBT): initial experience in a clinical setting.

BACKGROUND: Digital breast tomosynthesis (DBT) is a promising new technology. Some experimental clinical studies have shown positive results, but the future role and indications of this new technique, whether in a screening or clinical setting, need to be evaluated. PURPOSE: To compare digital mammography and DBT in a side-by-side feature analysis for cancer conspicuity, and to assess whether there is a potential additional value of DBT to standard state-of-the-art conventional imaging work-up with respect to detection of additional malignancies. MATERIAL AND METHODS: The study had ethics committee approval. A total of 129 women underwent 2D digital mammography including supplementary cone-down and magnification views and breast ultrasonography if indicated, as well as digital breast tomosynthesis. The indication for conventional imaging in the clinical setting included a palpable lump in 30 (23%), abnormal mammographic screening findings in 54 (42%), and surveillance in 45 (35%) of the women. The women were examined according to present guidelines, including spot-magnification views, ultrasonography, and needle biopsies, if indicated. The DBT examinations were interpreted several weeks after the conventional imaging without knowledge of the conventional imaging findings. In a later session, three radiologists performed a side-by-side feature analysis for cancer conspicuity in a sample of 50 cases. RESULTS: State-of-the-art conventional imaging resulted in needle biopsy of 45 breasts, of which 20 lesions were benign and a total of 25 cancers were diagnosed. The remaining 84 women were dismissed with a normal/definitely benign finding and without indication for needle biopsy. The subsequent DBT interpretation found suspicious findings in four of these 84 women, and these four women had to be called back for repeated work-up with knowledge of the tomosynthesis findings. These delayed work-ups resulted in two cancers (increasing the cancer detection by 8%) and two false-positive findings. The side-by-side feature analysis showed higher conspicuity scores for tomosynthesis compared to conventional 2D for cancers presenting as spiculated masses and distortions. CONCLUSION: Tomosynthesis is a promising new technique. Our preliminary clinical experience shows that there is a potential for increasing the sensitivity using this new technique, especially for cancers manifesting as spiculated masses and distortions.

Mammography screening using independent double reading with consensus: is there a potential benefit for computer-aided detection?

BACKGROUND: Double reading improves the cancer detection rate in mammography screening. Single reading with computer-aided detection (CAD) has been considered to be an alternative to double reading. Little is known about the potential benefit of CAD in breast cancer screening with double reading. PURPOSE: To compare prospective independent double reading of screen-film (SFM) and full-field digital (FFDM) mammography in population-based screening with retrospective standalone CAD performance on the baseline mammograms of the screen-detected cancers and subsequent cancers diagnosed during the follow-up period. MATERIAL AND METHODS: The study had ethics committee approval. A 5-point rating scale for probability of cancer was used for 23,923 (SFM = 16,983; FFDM = 6940) screening mammograms. Of 208 evaluable cancers, 104 were screen-detected and 104 were subsequent (44 interval and 60 next screening round) cancers. Baseline mammograms of subsequent cancers were retrospectively classified in consensus without information about cancer location, histology, or CAD prompting as normal, non-specific minimal signs, significant minimal signs, and false-negatives. The baseline mammograms of the screen-detected cancers and subsequent cancers were evaluated by CAD. Significant minimal signs and false-negatives were considered 'actionable' and potentially diagnosable if correctly prompted by CAD. RESULTS: CAD correctly marked 94% (98/104) of the baseline mammograms of the screen-detected cancers (SFM = 95% [61/64]; FFDM = 93% [37/40]), including 96% (23/24) of those with discordant interpretations. Considering only those baseline examinations of subsequent cancers prospectively interpreted as normal and retrospectively categorized as 'actionable', CAD input at baseline screening had the potential to increase the cancer detection rate from 0.43% to 0.51% (P = 0.13); and to increase cancer detection by 16% ([104 + 17]/104) and decrease interval cancers by 20% (from 44 to 35). CONCLUSION: CAD may have the potential to increase cancer detection by up to 16%, and to reduce the number of interval cancers by up to 20% in SFM and FFDM screening programs using independent double reading with consensus review. The influence of true- and false-positive CAD marks on decision-making can, however, only be evaluated in a prospective clinical study.