The clinical utility of a negative result at molecular breast imaging: Initial proof of concept

Abstract

Purpose: To calculate the negative predictive value (NPV) and false-negative rate (FNR) of molecular breast imaging (MBI) performed in patients who had low-suspicion index findings on mammograms and US images. Materials and Methods: This retrospective study included patients who had undergone MBI between January 2015 and July 2017, who had index findings on screening mammograms and/or US images, and for whom either histopathologic results or a minimum of 1-year imaging follow-up results were available. A drawn dose of 8 mCi (296 MBq) of technetium 99m sestamibi was administered to all patients for MBI. The NPV and FNR of MBI was calculated for the cohort of 381 findings among 338 women (median age, 56 years; age range, 28–89 years) included in this study. Results: Overall, 292 of the 381 (76.6%) MBI results were interpreted as negative. Of the 292, 27 patients underwent subsequent biopsies, results of which were negative for cancer; one patient underwent biopsy, and the result was positive for cancer; and 264 patients had true-negative findings based on follow-up imaging for a minimum of 1 year. Of the 89 MBI acquisitions interpreted as positive, there were 36 cancers. The NPV was calculated to be 99.7% (291 of 292, 95% confidence interval [CI]: 99.1%, 100%), and the FNR was 2.7% (one of 37, 95% CI: 0%, 7.9%). Interposing MBI reduced the number of biopsies by 67.5%. Conclusion: The concept of the clinical utility of a negative MBI result may be valid but requires further testing.