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RECRUITING
NCT06256705
NA

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

View on ClinicalTrials.gov

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

OTHER

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