Background: The Italian Tailored Assessment of Lung Indeterminate Accidental Nodule (ITALIAN) is a retrospective, multicenter trial designed to compare the diagnostic information provided by segmental positron emission tomography (PET)/computed tomography (CT) (s-PET/CT) with those of whole body (wb)-PET/CT in patients with single pulmonary nodules (SPN). This report describes the details and implications of the ITALIAN trial design.
Methods and results: Between September 2016 and May 2017, 502 consecutive patients (302 men, mean age 67±12 years) with SPN undergoing 18F-fluorodeoxyglucose (FDG) PET/CT were enrolled. PET/CT images will be visually and semiquantitatively evaluated. For visual analysis, a 4-point scoring system (1=absent; 2=mild; 3=moderate and 4=intense) will be used; for semiquantitative analysis, maximum standardized uptake value (SUV) in the SPN and mean SUV in the mediastinal blood pool and in the liver will be computed.
Conclusion: The results of this trial might help to define the role of s-PET/CT in patients with SPN. This trial will also evaluate the impact on radiobiology and costs subsequent the introduction of this alternative imaging acquisition modality.
Keywords: FDG PET/CT; SPN.; SUV; Single pulmonary nodule; cost-analysis; diagnostic performance; radiobiology.
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