Comparison of Radiologist Performance with Photon-Counting Full-Field Digital Mammography to Conventional Full-Field Digital Mammography

Rationale and Objectives: The purpose of this study was to assess the performance of a Micro Dose photon-counting full-field digital mammography (PCM) system in comparison to full-field digital mammography (FFDM) for area under the receiver-operating characteristic (ROC) curve (AUC), sensitivity, specificity, and feature analysis of standard-view mammography for women presenting for screening mammography, diagnostic mammography, or breast biopsy. Materials and Methods: A total of 133 women were enrolled in this study at two European medical centers, with 67 women who had a preexisting 10-36 months FFDM enrolled prospectively into the study and 66 women who underwent breast biopsy and had screening PCM and diagnostic FFDM, including standard craniocaudal and mediolateral oblique views of the breast with the lesion, enrolled retrospectively. The case mix consisted of 49 cancers, 17 biopsy-benign cases, and 67 normal cases. Sixteen radiologists participated in the reader study and interpreted all 133 cases in both conditions, separated by washout period of >= 4 weeks. ROC curve and free-response ROC curve analyses were performed for noninferiority of PCM compared to FFDM using a noninferiority margin Delta value of 0.10. Feature analysis of the 66 cases with lesions was conducted with all 16 readers at the conclusion of the blinded reads. Mean glandular dose was recorded for all cases. Results: The AUC for PCM was 0.947(95% confidence interval [CI], 0.920-0.974) and for FFDM was 0.931 (95% CI, 0.898-0.964). Sensitivity per case for PCM was 0.936(95% CI, 0.897-0.976) and for FFDM was 0.908(95% CI, 0.856-0.960). Specificity per case for PCM was 0.764(95% CI, 0.688-0.841) and for FFDM was 0.749(95% CI, 0.668-0.830). Free-response ROC curve figures of merit were 0.920(95% CI, 0.881-0.959) and 0.903(95% CI, 0.858-0.948) for PCM and FFDM, respectively. Sensitivity per lesion was 0.903(95% CI, 0.846-0.960) and 0.883 (95% CI, 0.823-0.944) for PCM and FFDM, respectively. The average false-positive marks per image of noncancer cases were 0.265(95% CI, 0.171-0.359) and 0.281 (95% CI, 0.188-0.374) for PCM and FFDM, respectively. Noninferiority P values for AUC, sensitivity (per case and per lesion), specificity, and average false-positive marks per image were all statistically significant (P <.001). The noninferiority P value for free-response ROC was <.025, from the 95% CI for the difference. Feature analysis resulted in PCM being preferred to FFDM by the readers for >= 70% of the cases. The average mean glandular dose for PCM was 0.74 mGy (95% CI, 0.722-0.759 mGy) and for FFDM was 1.23 mGy (95% CI, 1.199-1.262 mGy). Conclusions: In this study, radiologist performance with PCM was not inferior to that with conventional FFDM at an average 40% lower mean glandular dose.