18F-Fluciclovine PET imaging in glioma: feasibility study for prediction of low to high grade transformation – the FIG trial
Project Lead: Professor Geoff Higgins (University of Oxford)
18F-fluciclovine has been shown to be a promising imaging agent for positron emission tomography (PET) imaging of brain tumours.
Orphan drug designation has been granted for the 18F-fluciclovine radiotracer to be used in glioma patient studies by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). An early phase multicentre safety study has shown the potential of 18F-fluciclovine PET imaging for the detection of gliomas that were otherwise not detectable using contrast enhanced T 1-weighted magnetic resonance imaging (MRI). 1
The NCITA Exemplar 7 is a multicentre study which will assess the feasibility of performing 18F-fluciclovine PET and PET guided histopathology. The study will be set up initially at the University of Oxford, and will then be expanded to other NCITA host institutions including the University of Cambridge and Imperial College London.
This Exemplar study will provide the feasibility imaging data required to apply for further funding to perform a multicentre clinical evaluation study using 18F-fluciclovine PET imaging evaluating the diagnostic performance of 18F-fluciclovine PET in detecting high grade transformation in low grade gliomas.