Prospective comparison of CT and (18)F-FDG PET/MRI in N and M staging of primary breast cancer patients: Initial results

OBJECTIVES: To compare the diagnostic accuracy of contrast-enhanced thoraco-abdominal computed tomography and whole-body (18)F-FDG PET/MRI in N and M staging in newly diagnosed, histopathological proven breast cancer. MATERIAL AND METHODS: A total of 80 consecutive women with newly diagnosed and histopathologically confirmed breast cancer were enrolled in this prospective study. Following inclusion criteria had to be fulfilled: (1) newly diagnosed, treatment-naive T2-tumor or higher T-stage or (2) newly diagnosed, treatment-naive triple-negative tumor of every size or (3) newly diagnosed, treatment-naive tumor with molecular high risk (T1c, Ki67 >14%, HER2neu over-expression, G3). All patients underwent a thoraco-abdominal ceCT and a whole-body (18)F-FDG PET/MRI. All datasets were evaluated by two experienced radiologists in hybrid imaging regarding suspect lesion count, localization, categorization and diagnostic confidence. Images were interpreted in random order with a reading gap of at least 4 weeks to avoid recognition bias. Histopathological results as well as follow-up imaging served as reference standard. Differences in staging accuracy were assessed using Mc Nemars chi(2) test. RESULTS: CT rated the N stage correctly in 64 of 80 (80%, 95% CI:70.0–87.3) patients with a sensitivity of 61.5% (CI:45.9–75.1), a specificity of 97.6% (CI:87.4–99.6), a PPV of 96% (CI:80.5–99.3), and a NPV of 72.7% (CI:59.8–82.7). Compared to this, (18)F-FDG PET/MRI determined the N stage correctly in 71 of 80 (88.75%, CI:80.0–94.0) patients with a sensitivity of 82.1% (CI:67.3–91.0), a specificity of 95.1% (CI:83.9–98.7), a PPV of 94.1% (CI:80.9–98.4) and a NPV of 84.8% (CI:71.8–92.4). Differences in sensitivities were statistically significant (difference 20.6%, CI:-0.02–40.9; p = 0.008). Distant metastases were present in 7/80 patients (8.75%). (18) F-FDG PET/MRI detected all of the histopathological proven metastases without any false-positive findings, while 3 patients with bone metastases were missed in CT (sensitivity 57.1%, specificity 95.9%). Additionally, CT presented false-positive findings in 3 patients. CONCLUSION: (18)F-FDG PET/MRI has a high diagnostic potential and outperforms CT in assessing the N and M stage in patients with primary breast cancer.