Evaluation of single-view contrast-enhanced mammography as novel reading strategy: a non-inferiority feasibility study

M. B. Lobbes*, J. Hecker, I. P. L. Houben, R. Pluymakers, C. Jeukens, U. C. Laji, S. Gommers, J. E. Wildberger, P. J. Nelemans

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

4 Citations (Web of Science)

Abstract

Background Guidelines recommend screening of high-risk women using breast magnetic resonance imaging (MRI). Contrast-enhanced mammography (CEM) has matured, providing excellent diagnostic accuracy. To lower total radiation dose, evaluation of single-view (1 V) CEM exams might be considered instead of double-view (2 V) readings as an alternative reading strategy in women who cannot undergo MRI. Methods This retrospective non-inferiority feasibility study evaluates whether the use of 1 V results in an acceptable sensitivity for detecting breast cancer (non-inferiority margin, - 10%). CEM images from May 2013 to December 2017 were included. 1 V readings were performed by consensus opinion of three radiologists, followed by 2 V readings being performed after 6 weeks. Cases were considered "malignant" if the final BI-RADS score was >= 4, enabling calculation of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC). Histopathological results or follow-up served as a gold standard. Results A total of 368 cases were evaluated. Mean follow-up for benign or negative cases was 20.9 months. Sensitivity decreased by 9.6% from 92.9 to 83.3% when only 1 V was used for evaluation (p <0.001). The lower limit of the 90% confidence interval around the difference in sensitivity between 1 V and 2 V readings was - 15% and lies below the predefined non-inferiority margin of - 10%. Hence, non-inferiority of 1 V to 2 V reading cannot be concluded. AUC for 1 V was significantly lower, 0.861 versus 0.899 for 2 V (p = 0.0174). Conclusion Non-inferiority of 1 V evaluations as an alternative reading strategy to standard 2 V evaluations could not be concluded. 1 V evaluations had lower diagnostic performance compared with 2 V evaluations.

Original languageEnglish
Pages (from-to)6211-6219
Number of pages9
JournalEuropean Radiology
Volume29
Issue number11
DOIs
Publication statusPublished - Nov 2019

Keywords

  • Breast cancer
  • Screening
  • Mammography
  • BRCA MUTATION CARRIERS
  • RESONANCE-IMAGING MRI
  • SPECTRAL MAMMOGRAPHY
  • BREAST-CANCER
  • GADOLINIUM DEPOSITION
  • DIAGNOSTIC-ACCURACY
  • HIGH-RISK
  • WOMEN
  • RECOMMENDATIONS
  • BENEFIT

Cite this