Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456723
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-05-28
Brief Title:
Evaluation of 18FFluoroethyl Triazole Labelled Tyr3-Octreotate Analogues for the Imaging of Neuroendocrine Tumours
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Evaluation of 18FFluoroethyl Triazole Labelled Tyr3-Octreotate Analogues for the Imaging of Neuroendocrine Tumours
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FETONET
Brief 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 68GaGa-DOTA-peptides The 68GaGa-DOTA-peptide radiolabelled SSAs have significant limitations in terms of accessibility and low throughput The team at Imperial College London developed a novel radiotracer 18Ffluoroethyl 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 PETCT imaging following an injection of 18F-FET-βAG-TOCA with the view to compare the clinical utility of this radiotracer with 68GaGa-DOTA-peptide PET-CT in patients with NET
Detailed 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 68GaGa-DOTA-peptides The 68GaGa-DOTA-peptide radiolabelled SSAs have significant limitations in terms of accessibility and low throughput The team at Imperial College London developed a novel radiotracer 18Ffluoroethyl 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 35 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 PETCT imaging with 18F-FET-βAG-TOCA with the view to compare the clinical utility of 18F-FET-βAG-TOCA-PETCT with 68GaGa-DOTA-peptide PETCT standard of care in patients with NET
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None