Actively Recruiting
Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours Treated With Targeted Radionuclide Therapy: Prospective Interventional Multicentre National Cohort
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-22
80
Participants Needed
5
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a rare type of cancer affecting the digestive system. The study explores new ways to improve treatment with Peptide Receptor Radionuclide Therapy (PRRT), using advanced imaging techniques and data analysis. It aims to identify early markers that predict how well PRRT will work by analyzing detailed imaging and molecular data from a large group of patients. Participants will undergo Simultaneous 68Ga-DOTATOC PET-MRI scans before starting PRRT, midway through treatment, and one year after beginning therapy. This advanced imaging combines PET and MRI to provide detailed pictures of tumors and their biological activity. The study also includes methods like genomic profiling and testing new radionuclides to improve patient selection and treatment effectiveness. During the study, patients will be monitored through scheduled PET-MRI scans and clinical evaluations to track response to PRRT over 18 months. Researchers will assess tumor progression or patient survival as primary outcomes. The study collects clinical, molecular, and imaging data to develop better predictive tools and improve personalized treatment strategies for patients with advanced GEP-NETs.
CONDITIONS
Brief 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...
- Referred for PRRT according to multidisciplinary team decision
- Histologically confirmed unresectable GEP-NETs or NETs of unknown primary suspected of GEP origin
- Metastatic and progressive disease as per RECIST 1.1 criteria
- At least one measurable disease site per RECIST v1.1 on contrast-enhanced CT or MRI
- Somatostatin receptor positive disease shown by PET-DOTATOC within 4 months prior
- Majority of lesions and all target lesions must be somatostatin receptor positive
- Karnofsky performance status scale score of 60 or higher
- Life expectancy greater than 6 months
- Age 18 years or older
You will not qualify if you...
- Known pregnancy or breastfeeding
- Known allergy to 177Lu, octreotate, DOTA, 68Ga, Edotreotide, lysine, arginine, or amino acid solution excipients
- Contraindication or technical impossibility for MRI
- Prior external beam radiation or liver selective internal radiation within 12 weeks if extensive
- Other systemic antitumor treatments (except somatostatin analogues) not stopped for at least 4 weeks
- Mixed Neuroendocrine-Non-endocrine Neoplasms (MiNEN)
- Neuroendocrine carcinoma
- Uncontrolled brain metastasis for at least 3 months
- Severe heart failure (NYHA class 3 or 4)
- Inability to stop delayed-acting somatostatin analogues 28 days before PRRT or rapid-acting analogues 24 hours before
- Inadequate bone marrow, liver, or kidney function within 1 month prior to PRRT (specific lab criteria)
- Prior peptide receptor radionuclide therapy
- Other progressive cancers within last 3 years (except certain skin and cervical cancers)
- Refusal to give written informed consent
- Legal protective measures or deprivation of freedom
- No social security affiliation or state medical aid recipient
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of PRRT treatment cycles as per clinical care
Participants receive Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE. Simultaneous 68Ga-DOTATOC PET-MRI scans are performed to help predict treatment response and guide therapy.
3 PET-MRI scans: 1 month before first PRRT cycle, after second cycle, and 1 year after first cycle
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
L
Louis DE MESTIER
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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