Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort

NCT06256705 | Recruiting

• 1 other identifier: APHP230280
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Gastroenteropancreatic Neuroendocrine Tumor; Radiotherapy

Keywords

Targeted radionuclide therapy

Outcome Measures

Primary Outcomes (1)

• Clinical response defined by the PFS as the time measured from the day of first administration of PRRT to first progression or death at 18 months, whichever occurs first

  18 months after PRRT

Study Arms (1)

PET-MRI

EXPERIMENTAL

PET-MRI added in care pathway

Other: Simultaneous 68Ga-DOTATOC PET-MRI

Interventions

Simultaneous 68Ga-DOTATOC PET-MRI OTHER

on month before first cycle of 177Lu-DOTATATE, after second cycle and one year after first cycle

PET-MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According the MDT decision to refer to PRRT
• Histologically confirmed diagnosis of unresectable GEP-NETs whatever the grade or NETs of unknown primary but suspected of GEP origin
• Metastastic and progressive according RECIST 1.1 criteria
• At least 1 measurable site of disease per RECIST v1.1 using contrast-enhanced CT or magnetic resonance imaging
• The majority of the lesions and all RECIST 1.1 selected target lesion have to be SSTR+.
• Karnofsky performance status scale ≥ 60
• Live expectancy \>6 months
• Patients ≥ 18 years of age

You may not qualify if:

• Known pregnancy or breastfeeding women
• Known hypersensitivity to 177Lu, octreotate, DOTA, 68Ga, Edotreotide,
• Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective amino acid solution (AAS) given concomitantly to the 177Lu-DOTATATE infusion.
• Contraindication to MRI and technical impossibility of MRI
• Other systemic antitumor treatment (non-radioactive, excluding somatostatin analogues) not interrupted for at least 4 weeks
• Mixed Neuroendocrine-Non-endocrine Neoplasms (MiNEN)
• Neuroendocrine carcinoma
• Uncontrolled brain metastasis for at least 3 months
• NYHA 3 or 4 heart failure
• Inability to discontinue delayed-acting somatostatin analogues at least 28 days prior the PRRT or rapid-acting somatostatin analogues at least 24 hours prior the PRRT
• Non-adequate bone marrow, liver and renal function within 1 month prior the PRRT as assessed by the following laboratory tests:
• Platelet count \< 75,000/mm3
• Haemoglobin ≤ 8,0 g/dL
• Total bilirubin \> 3 ULN
• Neutrophils \< 1000/mm3

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (5)

Médecine nucléaire et Biophysique - Beaujon

Clichy, 92110, France

RECRUITING

Pancréatologie et Oncologie Digestive - Beaujon

Clichy, 92110, France

RECRUITING

Hépato-gastro-entérologie, cancérologie digestive et assistance nutritionnelle - CHU Nantes

Nantes, 44000, France

ACTIVE NOT RECRUITING

Médecine nucléaire - CHU Nantes

Nantes, 44000, France

RECRUITING

Service de Médecine Nucléaire, Groupe Hospitalier Bichat-Claude Bernard

Paris, 75018, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Central Study Contacts

Catherine ANSQUER

CONTACT

00-33-2-40-08-41-36; catherine.ansquer@chu-nantes.fr

Louis DE MESTIER

CONTACT

00-33-1-40-87-53-28; louis.demestier@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): September 25, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FR (5)