Clinical and FDG-PET/CT Suspicion of Malignant Disease: Is Biopsy Confirmation Still Necessary?

Background: Biopsy of (18)F-fluoro-2-deoxy-D-glucose (FDG)-avid lesions suspected for malignancy remains an invasive procedure associated with a variety of risks. It is still unclear if the positive predictive value (PPV) of positron emission tomography (PET)/computed tomography (CT) is sufficiently high to avoid tissue sampling. Therefore, the purpose of this study was to determine the PPV of (18)F-FDG-PET/CT for malignancy in patients with a clinical suspicion of active malignant disease. Methods: This single-center retrospective study included 83 patients who had undergone FDG-PET/CT within 60 days before CT- or ultrasonography-guided tissue sampling and whose request form for CT- or US-guided tissue sampling requested mutation analyses. The latter implies a high clinical suspicion of active malignant disease. The nature of each biopsied lesion was determined based on the results of the pathological analysis and/or clinical and imaging follow-up of at least 12 months. Results: In total, eighty-eight FDG-avid lesions were biopsied. The PPV of FDG-PET/CT for malignancy was 98.9% (95% CI: 93.8–99.8%). For patients with an oncological history, the PPV was 98.7% (95% CI: 92.9–99.8%), and for patients with no oncological history, the PPV was 100% (95% CI: 74.1–100.0%). There was no significant difference between the PPV of the group with and without an oncological history (p = 0.71). In two cases, an unsuspected malignancy was diagnosed. Conclusion: Although the PPV of FDG-PET/CT for malignancy in patients with a clinical suspicion of active malignant disease is high, biopsy remains recommended to avoid inappropriate patient management due the non-negligible chance of dealing with FDG-avid benign disease or unexpected malignancies.