Rationale and Objectives
Assess results of a prospective, single-site clinical study evaluating digital breast tomosynthesis (DBT) during baseline screening mammography.
Materials and Methods
Under an institutional review board–approved Health Insurance Portability and Accountability Act (HIPAA)-compliant protocol, consenting women between ages 34 and 56 years scheduled for their initial and/or baseline screening mammogram underwent both full field digital mammography (FFDM) and DBT. The FFDM and the FFDM plus DBT images were interpreted independently in a reader by mode balanced approach by two of 14 participating radiologists. A woman was recalled for a diagnostic work-up if either radiologist recommended a recall. We report overall recall rates and related diagnostic outcome from the 1080 participants. Proportion of recommended recalls (Breast Imaging Reporting and Data System 0) were compared using a generalized linear mixed model (SAS 9.3) with a significance level of P = .0294.
Results
The fraction of women without breast cancer recommended for recall using FFDM alone and FFDM plus DBT were 412 of 1074 (38.4%) and 274 of 1074 (25.5%), respectively ( P < .001). Large inter-reader variability in terms of recall reduction was observed among the 14 readers; however, 11 of 14 readers recalled fewer women using FFDM plus DBT (5 with P < .015). Six cancers (four ductal carcinomas in situ [DCIS] and two invasive ductal carcinomas [IDC]) were detected. One IDC was detected only on DBT and one DCIS cancer was detected only on FFDM, whereas the remaining cancers were detected on both modalities.
Conclusions
The use of FFDM plus DBT resulted in a significant decrease in recall rates during baseline screening mammography with no reduction in sensitivity.
Introduction
As wide spread periodic mammographic screening is now an acceptable practice in the United States and many other countries, our understanding of strategic, operational, and financial issues related to this practice is continually improving. Several performance measures have been used to define practice parameters in screening mammography, such as sensitivity, specificity, recall rate, positive predictive value, person-year-saved per examination, and cost per detected cancer . To date, despite the continuing controversy about the impact of recall rates on the overall cost benefit of screening mammography , the primary focus in screening has been on improving sensitivity. Although studies have shown that women who had false-positive mammograms remain likely to return for subsequent screening , there is still some uncertainty regarding the possible effects false-positive mammograms may have on future compliance and participant attitudes toward screening . This may especially be true for younger women participating in screening mammography for the first time for whom there are no prior images for comparison and who do not have previous experience with undergoing the procedure or being called back for further evaluation. As expected, higher recall rates than those during repeat screening have been reported in women with no prior mammograms . This issue raises concern because, in addition to the operational and financial burden , women who have been recalled experience an added level of anxiety . There is a general belief that through a variety of actions, including possibly targeted training, radiologists’ performance levels could be improved in this regard . However, to our knowledge, currently, there is no focused effort and/or specific training related to the interpretation of baseline mammograms (ie, without priors).
Although not specifically regulated, there is a practice guideline in the United States to maintain an overall recall rate benchmark below 10% for the general mammography screening population that includes a mix of baseline and repeat screening . The question of what effect, if any, does a forced reduction of recall rates have on detection rates remains somewhat controversial. However, there is a widely accepted belief that despite a demonstrated correlation between recall rates and cancer detection rates, it is important to keep recall rates as low as reasonably achievable . One possible approach to reduce recall rates in baseline screening mammography procedures is to use digital breast tomosynthesis (DBT) as a recommended standard of practice . DBT offers an approximation to a three-dimensional viewing of the breast, thereby eliminating some of the difficulties in correctly interpreting mammograms because of overlapping imaged tissue , and has been shown to reduce overall recall rates in retrospective studies and in clinical practice . However, there are no reports to date focusing specifically on the use of DBT in baseline mammograms. We report here on a single institution prospective screening study that included independent viewing and interpretation of full field digital mammography (FFDM) alone versus FFDM plus DBT acquired on younger women receiving baseline examinations. The decision to focus on younger women receiving baseline screening was solely based on the assumption that this population could potentially benefit the most in terms of a reduction in recall rates when using DBT during a baseline screening examination.
Materials and methods
Study Population
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Image Acquisition
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Image Interpretation
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Data Analysis
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Results
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Table 1
Distribution of Subjective Breast Density BI-RADS Ratings with Average Age in Each of the Density Groups
BI-RADS ∗ Number of Cases Percentage Average Age, y Standard Deviation 1 54 5.0 43.8 ±4.20 2 433 40.1 42.1 ±3.82 3 549 50.8 41.9 ±3.65 4 44 4.1 40.7 ±2.90
BI-RADS, Breast Imaging-Reporting and Data System.
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Table 2
The Number of Cases Recalled (and Not Recalled) by the Different Interpreters Under Each of the Reading Modes in Women without Breast Cancer
FFDM Only Recalled FFDM Only Not Recalled Total FFDM+DBT Recalled 176 98 274 FFDM+DBT Not Recalled 236 564 800 Total 412 662 1074
DBT, digital breast tomosynthesis; FFDM, full field digital mammography.
Table 3
Number of Baseline Screening Interpretations by Each of the Readers and the Number of Examinations Recommended for a Recall by Reader and Mode in Women without Breast Cancer
Reader FFDM FFDM + DBT_P_ Value Number of Cases Number of Recalls % Number of Cases Number of Recalls % Reader 1 4 1 25 4 0 0 1.00 Reader 2 114 35 31 127 18 14 <.01 Reader 3 8 4 50 8 4 50 1.00 Reader 4 156 33 21 175 19 11 .01 Reader 5 2 1 50 1 1 100 1.00 Reader 6 51 18 35 63 21 33 .85 Reader 7 175 63 36 158 46 30 .20 Reader 8 179 91 51 180 73 41 .06 Reader 9 1 1 100 1 1 100 1.00 Reader 10 51 17 33 53 15 28 .67 Reader 11 53 33 62 54 19 35 <.01 Reader 12 89 39 44 85 14 16 <.01 Reader 13 140 56 40 129 30 23 <.01 Reader 14 51 20 39 36 13 38 .83 Totals 1074 412 38 1074 274 26 <.001
DBT, digital breast tomosynthesis; FFDM, full field digital mammography.
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Table 4
Biopsy Outcome by Mode of Interpretation of the Baseline Screening Examination that Resulted in a Recall Recommendation
Recalled by Biopsy Outcome Totals Benign High Risk Cancer FFDM only reader 27 3 1 31 FFDM + DBT reader 15 2 1 18 Both readers 34 8 4 46 Totals 76 13 6 95
DBT, digital breast tomosynthesis; FFDM, full field digital mammography.
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Discussion
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Conclusion
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Acknowledgments
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