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OBJECTIVE: To assess the clinical effect of an early follow-up positron emission tomography (PET) examination at the time of the first routine clinical control in patients with advanced-stage head and neck squamous cell carcinoma (HNSCC). DESIGN: Prospective, nonrandomized, case-control study. SETTING: Single referral center. PATIENTS AND INTERVENTION: A total of 26 patients (mean age, 56 years) with histologically confirmed stage III-IV HNSCC underwent PET before and approximately 6 weeks after the end of a combined treatment with radiation and chemotherapy with curative intent. The PET findings were confirmed by histologic analysis and a 6-month clinical follow-up. MAIN OUTCOME MEASURES: The presence of distant metastases, secondary synchronous cancers, and residual locoregional tissue was confirmed, and the effect on further clinical management was assessed. RESULTS: Using PET, we correctly identified residual tumor tissue, distant metastases, or a second primary tumor in 10 patients, 5 of whom had no clinical evidence of such findings. Results were true negative in 14 cases; false positive in 1; and false negative in 1. Sensitivity and specificity for follow-up PET scans were 90.9% and 93.3%, respectively. All patients with positive findings were evaluated for further treatment such as salvage surgery. CONCLUSIONS: Whole-body PET scanning approximately 6 weeks after completion of a combined treatment regimen with radiation and chemotherapy can reliably identify locoregional residual cancer and distant metastases or secondary tumors in patients with advanced-stage HNSCC and has a direct influence on management decisions.