Benefits and harms of implementing [18F]FDG-PET/CT for diagnosing recurrent breast cancer: a prospective clinical study

Abstract Background [ 18 F]-fluorodeoxyglucose-positron emission tomography/computed tomography ([ F]FDG-PET/CT) has been implemented sporadically in hospital settings as the standard of care examination for recurrent breast cancer. We aimed to explore clinical impact implementing F]FDG-PET/CT patients with clinically suspected cancer and validate diagnostic accuracy. Methods Women distant were prospectively enrolled study between September 2017 August 2019. was performed, appearance incidental benign malignant findings registered. Additional examinations, complications, final diagnosis registered reflect consequence such findings. The accuracy a stand-alone analyzed. Biopsy follow-up used reference standard. Results reported metastases 72 225 women (32.0%), verified by biopsy 52 (52/225, 23.1%). Prior probability posterior positive test metastatic malignancies 27%/85% 4%/20%, respectively. Suspected 46 (46/225, 20.4%), leading further examinations detection nine synchronous cancers (9/225, 4.0%). These originated from lung, thyroid, skin, pancreas, peritoneum, breast, kidney, one melanoma, hematological False-positive examined 37/225 (16.4%), mainly colon ( n = 12) thyroid gland 12). Ten suspicious disease suggested F]FDG-PET/CT, resulted three conditions requiring treatment. Sensitivity, specificity, AUC-ROC diagnosing 1.00 (0.93–1.0), 0.88 (0.82–0.92), 0.98 (95% CI 0.97–0.99), Conclusion provided high test, negative able rule out One-fifth detected on diagnosed relevant conditions. Further false-positive six should be weighed against Trial registration Clinical.Trials.gov. NCT03358589. Registered 30 November 2017—Retrospectively registered, http://www.ClinicalTrials.gov