NR Qureshi, RC Rintoul, KA Miles, S George, S Harris, J Madden, K Cozens, LA Little, K Eichhorst, J Jones, P Moate, C McClement, L Pike, D Sinclair, WL Wong, J Shekhdar, R Eaton, A Shah, L Brindle, C Peebles, A Banerjee, S Dizdarevic, S Han, FW Poon, AM Groves, L Kurban, AJ Frew, ME Callister, P Crosbie, FV Gleeson, K Karunasaagarar, O Kankam, FJ Gilbert
BMJ Open Respir Res
INTRODUCTION: Solitary pulmonary nodules (SPNs) are common on CT. The most cost-effective investigation algorithm is still to be determined. Dynamic contrast-enhanced CT (DCE-CT) is an established diagnostic test not widely available in the UK currently. METHODS AND ANALYSIS: The SPUtNIk study will assess the diagnostic accuracy, clinical utility and cost-effectiveness of DCE-CT, alongside the current CT and 18-flurodeoxyglucose-positron emission tomography) (18FDG-PET)-CT nodule characterisation strategies in the National Health Service (NHS). Image acquisition and data analysis for 18FDG-PET-CT and DCE-CT will follow a standardised protocol with central review of 10% to ensure quality assurance. Decision analytic modelling will assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs. ETHICS AND DISSEMINATION: Approval has been granted by the South West Research Ethics Committee. Ethics reference number 12/SW/0206. The results of the trial will be presented at national and international meetings and published in an Health Technology Assessment (HTA) Monograph and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN30784948; Pre-results.