Evaluation of [18F]Fluoroethyl Triazole Labelled [Tyr3]-Octreotate Analogues for the Imaging of Neuroendocrine Tumours.
Status:
COMPLETED
Trial end date:
2018-10-17
Target enrollment:
Participant gender:
Summary
Radiolabelled somatostatin analogs are invaluable in the diagnosis and treatment of neuroendocrine tumours (NET). The most common positron emission tomography (PET) radiotracers used for the visualisation of NET are radiolabelled somatostatin analogs (SSAs) labelled with \[68Ga\]Ga-DOTA-peptides. However, \[68Ga\]Ga-DOTA-peptide radiolabelled SSAs have significant limitations in terms of accessibility and low throughput. The team at Imperial College London developed a novel radiotracer, \[18F\]fluoroethyl triazole labelled \[Tyr3\]-Octreotate analogue (\[18F\]-FET-βAG-TOCA), in an attempt to overcome these limitations. The FETONET study was designed to have 3 parts. The FETONET study was designed to have 3 parts. Part A evaluated the biodistribution, dosimetry and safety of \[18F\]FET-βAG-TOCA. Uptake was assessed at multiple time points over a 4 hour period. The data was analysed and an optimal imaging time point determined. Part B of the FETONET study involved the performance of whole body static \[18F\]FET-βAG-TOCA PET-CT imaging, at the optimal time point previously established, within a larger cohort of patients. Part C comprised a prospective non-inferiority study that analysed the \[18F\]FET-βAG-TOCA PET/CT data collected within Part A \& Part B and compared this to standard of care \[Ga68\]Ga-DOTA-peptide PET-CT imaging.
Phase:
PHASE1
Details
Lead Sponsor:
Imperial College London
Collaborators:
Imperial College Healthcare NHS Trust Invicro Newcastle University Royal Marsden NHS Foundation Trust The Christie NHS Foundation Trust University of Manchester