Prospective evaluation of whole-body MRI and (18)F-FDG PET/MRI in N and M staging of primary breast cancer patients

OBJECTIVES: To evaluate and compare the diagnostic potential of whole-body MRI and whole-body (18)F-FDG PET/MRI for N and M staging in newly diagnosed, histopathologically proven breast cancer. MATERIAL AND METHODS: A total of 104 patients (age 53.4 ± 12.5) with newly diagnosed, histopathologically proven breast cancer were enrolled in this study prospectively. All patients underwent a whole-body (18)F-FDG PET/MRI. MRI and (18)F-FDG PET/MRI datasets were evaluated separately regarding lesion count, lesion localization, and lesion characterization (malignant/benign) as well as the diagnostic confidence (5-point ordinal scale, 1–5). The N and M stages were assessed according to the eighth edition of the American Joint Committee on Cancer staging manual in MRI datasets alone and in (18)F-FDG PET/MRI datasets, respectively. In the majority of lesions histopathology served as the reference standard. The remaining lesions were followed-up by imaging and clinical examination. Separately for nodal-positive and nodal-negative women, a McNemar chi(2) test was performed to compare sensitivity and specificity of the N and M stages between (18)F-FDG PET/MRI and MRI. Differences in diagnostic confidence scores were assessed by Wilcoxon signed rank test. RESULTS: MRI determined the N stage correctly in 78 of 104 (75%) patients with a sensitivity of 62.3% (95% CI: 0.48–0.75), a specificity of 88.2% (95% CI: 0.76–0.96), a PPV (positive predictive value) of 84.6% % (95% CI: 69.5–0.94), and a NPV (negative predictive value) of 69.2% (95% CI: 0.57–0.8). Corresponding results for (18)F-FDG PET/MRI were 87/104 (83.7%), 75.5% (95% CI: 0.62–0.86), 92.2% (0.81–0.98), 90% (0.78–0.97), and 78.3% (0.66–0.88), showing a significantly better sensitivity of (18)F-FDG PET/MRI determining malignant lymph nodes (p = 0.008). The M stage was identified correctly in MRI and (18)F-FDG PET/MRI in 100 of 104 patients (96.2%). Both modalities correctly staged all 7 patients with distant metastases, leading to false-positive findings in 4 patients in each modality (3.8%). In a lesion-based analysis, (18)F-FDG PET/MRI showed a significantly better performance in correctly determining malignant lesions (85.8% vs. 67.1%, difference 18.7% (95% CI: 0.13–0.26), p < 0.0001) and offered a superior diagnostic confidence compared with MRI alone (4.1 ± 0.7 vs. 3.4 ± 0.7, p < 0.0001). CONCLUSION: (18)F-FDG PET/MRI has a better diagnostic accuracy for N staging in primary breast cancer patients and provides a significantly higher diagnostic confidence in lesion characterization than MRI alone. But both modalities bear the risk to overestimate the M stage.