title: Considerations for generic oncology FDG-PET/CT protocol preparation in drug development.
abstract: [18F]Fluorodeoxyglucose (FDG)-PET combined with CT is increasingly being used as an imaging tool in oncology clinical trials. Progress in the standardization and harmonization of acquisition and analysis protocols for FDG-PET/CT has been made, although there are still areas for which further guidance is needed. Standardizing FDG-PET/CT clinical trial design and interpretation will contribute to increased efficiency and precision in decision-making for drug development. This feature review highlights areas in FDG-PET/CT imaging, particularly image analysis and response classification, that currently require expert guidance or further research to optimize the application of this tool in oncological drug development.
authors.affiliation: GlaxoSmithKline plc, London, UK.
authors.forename: William A
authors.initials: WA
authors.lastname: Hallett
authors.forename: R Paul
authors.initials: RP
authors.lastname: Maguire
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: McCarthy
authors.forename: Mark E
authors.initials: ME
authors.lastname: Schmidt
authors.forename: Helen
authors.initials: H
authors.lastname: Young
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards; D015195:Drug Design; D019788:Fluorodeoxyglucose F18; D006801:Humans; D015233:Models, Statistical; D009369:Neoplasms / Q000175:diagnosis*; D018579:Patient Selection; D049268:Positron-Emission Tomography / Q000295:instrumentation / Q000379:methods*; D019275:Radiopharmaceuticals; D012107:Research Design / Q000592:standards; D014057:Tomography, X-Ray Computed / Q000295:instrumentation / Q000379:methods*
chemical_list: D019275:Radiopharmaceuticals; D019788:Fluorodeoxyglucose F18