drugset / Trial / NCT06456723

Evaluation of [18F]Fluoroethyl Triazole Labelled [Tyr3]-Octreotate Analogues for the Imaging of Neuroendocrine Tumours.

NCT06456723 ↗

Non-randomizedSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2014-05-14
Primary completion
2018-10-17
Completion
2018-10-17

Outcome

Met primary endpoint

paper Conclusion: [18F]FET-βAG-TOCA was not inferior to [68Ga]Ga-DOTA-peptide in visualizing NET PMID 38331457 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject [18F]FET-βAG-TOCA Unknown 370 mbq Intravenous