indeterminate lung nodule spot on the lung
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 18 years or older able to give informed consent signed informed consent confirmed indeterminate lung nodule(s) of 6-15 mm in size on CT chest imaging routine [18]F-FDG PET/CT scheduled for biopsy or surgical removal of the lung nodule(s)
Exclusion criteria
Exclusion criteria: claustrophobic pregnant or breastfeeding women interval of at least 2 weeks between PET scan and last date of systemic anti-cancer therapy radiation therapy of the target lung nodule(s) uncontrolled diabetes mellitus any medical condition potentially hampering conduction of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is a technical performance assessment of lung nodule characterization using the Vision Quadra PET/CT. | — |
Secondary
| Measure | Time frame |
|---|---|
| To develop an optimized long FOV PET/CT imaging procedure (with regard to optimal scan duration and reconstruction parameters) for detection and characterization of indeterminate lung nodules, and to obtain preliminary data on sensitivity, specificity, and accuracy of PET imaging using the Vision Quadra PET/CT for small, indeterminate lung nodules. | — |
Countries
Netherlands