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Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Operandi project aims to address unmet clinical needs in the current management of GEP-NETs treated with PRRT by exploring new opportunities provided by imaging-based (AI algorithms) and data augmentation, simultaneous 68Ga-DOTATOC PET-MRI imaging, and novel approaches to increase patient selection and PRRT efficacy (genomic profiling, radiopotentiators, and new radionuclides). The study aim to identify predictive and early markers indicative of PRRT effectiveness based on a large prospective cohort of GEP-NET patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 68Ga-DOTATOC PET-MRI. Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic PET-MRI at baseline, at mid course of PRRT and 1 year after PRRT initiation, in patients with advanced GEP-NETs treated with PRRT.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-03-25
Completion Date
2029-09-25
Last Updated
2025-09-22
Healthy Volunteers
No
Interventions
Simultaneous 68Ga-DOTATOC PET-MRI
on month before first cycle of 177Lu-DOTATATE, after second cycle and one year after first cycle
Locations (5)
Médecine nucléaire et Biophysique - Beaujon
Clichy, France
Pancréatologie et Oncologie Digestive - Beaujon
Clichy, France
Hépato-gastro-entérologie, cancérologie digestive et assistance nutritionnelle - CHU Nantes
Nantes, France
Médecine nucléaire - CHU Nantes
Nantes, France
Service de Médecine Nucléaire, Groupe Hospitalier Bichat-Claude Bernard
Paris, France