Actively Recruiting
Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-22
80
Participants Needed
5
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Decision by multidisciplinary team to refer patient for PRRT
- Histologically confirmed unresectable GEP-NETs or NETs of unknown primary suspected to be of GEP origin
- Metastatic and progressive disease according to RECIST 1.1 criteria
- At least one measurable disease site per RECIST 1.1 on contrast-enhanced CT or MRI
- Somatostatin receptor positive disease shown by PET-DOTATOC within 4 months before inclusion
- Majority of lesions and all target lesions must be somatostatin receptor positive
- Karnofsky performance status of 60 or higher
- Life expectancy greater than 6 months
- Patients aged 18 years or older
You will not qualify if you...
- Known pregnancy or breastfeeding
- Known allergy to 177Lu, octreotate, DOTA, 68Ga, Edotreotide
- Known allergy to lysine, arginine, or any component of nephroprotective amino acid solution given with 177Lu-DOTATATE
- Contraindication or inability to undergo MRI
- Extensive prior external beam radiation or liver internal radiation within 12 weeks before inclusion
- Other systemic antitumor treatments (except somatostatin analogues) not stopped for at least 4 weeks
- Mixed neuroendocrine-non-endocrine neoplasms (MiNEN)
- Neuroendocrine carcinoma
- Uncontrolled brain metastases within last 3 months
- Severe heart failure (NYHA class 3 or 4)
- Inability to stop delayed-acting somatostatin analogues 28 days or rapid-acting analogues 24 hours before PRRT
- Inadequate bone marrow, liver, or kidney function according to recent lab tests
- Prior PRRT treatment
- Other progressive cancers within last 3 years except in situ cervical cancer and certain skin cancers
- Refusal to give informed consent
- Legal protection measures restricting participation
- Lack of social security or medical insurance coverage
- Patient receiving State Medical Aid
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Médecine nucléaire et Biophysique - Beaujon
Clichy, France, 92110
Actively Recruiting
2
Pancréatologie et Oncologie Digestive - Beaujon
Clichy, France, 92110
Actively Recruiting
3
Hépato-gastro-entérologie, cancérologie digestive et assistance nutritionnelle - CHU Nantes
Nantes, France, 44000
Active, Not Recruiting
4
Médecine nucléaire - CHU Nantes
Nantes, France, 44000
Actively Recruiting
5
Service de Médecine Nucléaire, Groupe Hospitalier Bichat-Claude Bernard
Paris, France, 75018
Active, Not Recruiting
Research Team
C
Catherine ANSQUER
CONTACT
L
Louis DE MESTIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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