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

Neuroendocrine Tumors Clinical Trial

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

Status Completed

Clinical Trial Summary

Radiolabelled somatostatin analogs are invaluable in the diagnosis and treatment of neuroendocrine tumours (NET). The most commonly used positron emission tomography (PET) radiotracers used for the visualisation of NET are radiolabelled somatostatin analogs (SSAs) labelled with [68Ga]Ga-DOTA-peptides. The [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. Within the FETONET study, two cohorts of patients will undergo PET/CT imaging following an injection of [18F]-FET-βAG-TOCA, with the view to compare the clinical utility of this radiotracer with [68Ga]Ga-DOTA-peptide PET-CT in patients with NET.

Clinical Trial Description

Neuroendocrine tumours (NET) are tumours derived from enterochromaffin cells, which are characterised by the expression of somatostatin receptors (SSTRs) on their surface. These tumours release substances into systemic circulation, resulting in episodic flushing, wheezing, diarrhoea, and eventual right-sided valvular heart disease. All of these symptoms negatively impact on patients' quality of life. The management of NET is primarily determined by the stage of disease. For patients with localised or limited disease the primary modality of therapy is surgery. Whilst patients with metastatic disease, undergo systemic therapy with palliative intent. Accurate imaging is therefore central to the management of this disease. Whilst computed tomography (CT) is useful in the localisation of NET, nuclear imaging using tumour-specific radiolabelled receptors are considerably more sensitive and specific methods for detecting NET and their metastases. The most commonly used positron emission tomography (PET) radiotracers used for the visualisation of NET are radiolabelled somatostatin analogs (SSAs) labelled with [68Ga]Ga-DOTA-peptides. The [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 recruited two cohorts of patients. Patients within Cohort 1 will be consented to undergo whole body dynamic scanning (multiple whole-body scans for up to 3.5 hours) with metabolite analysis, with the view to developing a suitable protocol for static scanning that will be used for patients in Cohort 2. Patients within Cohort 2 will consent to undergo static PET/CT imaging with [18F]-FET-βAG-TOCA, with the view to compare the clinical utility of [18F]-FET-βAG-TOCA-PET/CT with [68Ga]Ga-DOTA-peptide PET/CT (standard of care) in patients with NET. ;

Related Conditions & MeSH terms

• Neuroendocrine Tumors

• NCT number: NCT06456723
• Study type: Interventional
• Source: Imperial College London
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 14, 2014
• Completion date: October 17, 2018