Purpose: To prospectively determine sensitivity and specificity of breast magnetic resonance (MR) imaging in a screening and symptomatic population by using independent double reading, with histologic or cytologic results or a minimum 18-month follow-up as the standard.
Materials and methods: Informed consent and ethical approval were obtained. Reader performance was analyzed in 44 radiologists at 18 centers from 1541 examinations, including 1441 screening examinations in 638 high-risk women aged 24-51 years (mean, 40.5 years) and 100 examinations in symptomatic women aged 23-81 years (mean, 49.2 years). A screening protocol of dynamic T1-weighted three-dimensional imaging and 0.2 mmol/kg gadolinium-based intravenous contrast agent was used. Logistic and Poisson regressions were used to analyze reader performance in relation to experience. Correlation between readers was determined with kappa statistics. Sensitivity and specificity were analyzed according to reader, field strength, machine type, and histologic results.
Results: The proportion of studies with lesions analyzed reduced significantly with reader experience (odds ratio, 0.84 per 6 months; P < .001), and number of regions per lesion analyzed also diminished (incidence rate ratio, 0.98 per 6 months; P = .047). The two readers for each study agreed 87% of the time, with a moderately good kappa statistic of 0.52 (95% confidence interval [CI]: 0.45, 0.58). By taking the reading with the highest score (most likely to be malignant) from each double-read study, sensitivity was 91% (95% CI: 83%, 96%) and specificity was 81% (95% CI: 79%, 83%). Single readings had 7% lower sensitivity (95% CI: 4%, 11%) and 7% higher specificity (95% CI: 6%, 7%). Sensitivity did not differ between MR imager manufacturers or between 1.0- and 1.5-T field strength, but there were significant differences in specificity for machine type (P = .001) and for field strength adjusted for manufacturer (P = .001). Specificity, but not sensitivity, was higher in women younger than 50 years (P = .02).
Conclusion: Independent double reading by 44 radiologists blinded to mammography results showed sensitivity and specificity acceptable for screening; sensitivity was higher when two readings were used, at the cost of specificity. Interreader correlation was moderately good, and evidence of learning was seen. Equipment manufacturer, field strength, and age affected specificity but not sensitivity.