Stereoscopic digital mammography: improved specificity and reduced rate of recall in a prospective clinical trial
Department of Radiology
Adult; Aged; Aged, 80 and over; Breast Neoplasms; Female; Georgia; Humans; Imaging, Three-Dimensional; Mammography; Middle Aged; Prevalence; Prospective Studies; Radiographic Image Enhancement; Reproducibility of Results; Risk Factors; Sensitivity and Specificity
Clinical Trials | Diagnosis | Investigative Techniques | Radiology
PURPOSE: To compare stereoscopic digital mammography (DM) with standard DM for the rate of patient recall and the detection of cancer in a screening population at elevated risk for breast cancer.
MATERIALS AND METHODS: Starting in September 2004 and ending in December 2007, this prospective HIPAA-compliant, institutional review board-approved screening trial, with written informed consent, recruited female patients at elevated risk for breast cancer (eg, personal history of breast cancer or breast cancer in a close relative). A total of 1298 examinations from 779 patients (mean age, 58.6 years; range, 32-91 years) comprised the analyzable data set. A paired study design was used, with each enrolled patient serving as her own control. Patients underwent both DM and stereoscopic DM examinations in a single visit, findings of which were interpreted independently by two experienced radiologists, each using a Breast Imaging Reporting and Data System (BI-RADS) assessment (BI-RADS category 0, 1, or 2). All patients determined to have one or more findings with either or both modalities were recalled for standard diagnostic evaluation. The results of 1-year follow-up or biopsy were used to determine case truth.
RESULTS: Compared with DM, stereoscopic DM showed significantly higher specificity (91.2% [1167 of 1279] vs 87.8% [1123 of 1279]; P = .0024) and accuracy (90.9% [1180 of 1298] vs 87.4% [1135 of 1298]; P = .0023) for detection of cancer. Sensitivity for detection of cancer was not significantly different for stereoscopic DM (68.4% [13 of 19]) compared with DM (63.2% [12 of 19], P .99). The recall rate for stereoscopic DM was 9.6% (125 of 1298) and that for DM was 12.9% (168 of 1298) (P = .0018).
CONCLUSION: Compared with DM, stereoscopic DM significantly improved specificity for detection of cancer, while maintaining comparable sensitivity. The recall rate was significantly reduced with stereoscopic DM compared with DM.
SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.12120382/-/DC1.
DOI of Published Version
Radiology. 2013 Jan;266(1):81-8. doi: 10.1148/radiol.12120382. Epub 2012 Nov 13. Link to article on publisher's site
D'Orsi, Carl J.; Getty, David J.; Pickett, Ronald M.; Sechopoulos, Ioannis; Newell, Mary S.; Gundry, Kathleen R.; Bates, Sandra R.; Nishikawa, Robert M.; Sickles, Edward A.; Karellas, Andrew; and D'Orsi, Ellen M., "Stereoscopic digital mammography: improved specificity and reduced rate of recall in a prospective clinical trial" (2013). Radiology Publications and Presentations. 72.