Italian Tailored Assessment of Lung Indeterminate Accidental Nodule by Proposing a Segmental PET/Computed Tomography (s-PET/CT): Rationale and Study Design of a Retrospective, Multicenter Trial

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.