Additional value of FDG-PET to contrast enhanced-computed tomography (CT) for the diagnosis of mediastinal lymph node metastasis in non-small cell lung cancer: a Japanese multicenter clinical study

摘要

Objective This study was a controlled multicenter clinical study to verify the diagnostic effects of additional FDG-PET to contrast-enhanced CT for mediastinal lymph node metastasis in patients with operable non-small cell lung cancer (NSCLC).Methods NSCLC patients with enlarged mediastinal lymph nodes (short diameter, 7-20 mm), confirmed using contrast-enhanced CT, were examined using FDG-PET to detect metastases prior to surgery. The primary endpoint was the accuracy for concomitantly used CT and FDG-PET showing the additional effects of FDG, compared with CT alone. The secondary endpoints were the clinical impact of FDG-PET on therapeutic decisions and adverse reaction from FDG administration. The images were interpreted by investigators at each institution. Moreover, blinded readings were performed by an image interpretation committee independent of the institutions. The gold standard was the pathological diagnosis determined by surgery or biopsy after PET, and patients in whom a pathological diagnosis was not obtained were excluded from the analysis.