RecruitingNot ApplicableNCT06256705

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

Enrollment

80 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking people with neuroendocrine tumors of the gut or pancreas (GEP-NETs) who are being treated with a type of targeted radiation therapy called PRRT (peptide receptor radionuclide therapy). Researchers want to better understand how these tumors respond to treatment over time using multiple types of imaging and testing. **You may be eligible if...** - You are 18 or older - You have been diagnosed with an inoperable GEP-NET that is spreading or growing - Your tumor has a specific protein marker (somatostatin receptor positive) confirmed by a special scan - Your doctor has recommended PRRT as your treatment - You are in reasonably good general health (Karnofsky score ≥60) - Your expected survival is more than 6 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy to the treatment materials (including Lutetium-177 or amino acid solutions) - You cannot have an MRI scan - You received extensive radiation to liver tumors in the past 12 weeks - You have uncontrolled brain metastases - Your heart, bone marrow, liver, or kidney function does not meet minimum requirements - You have previously received PRRT treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSimultaneous 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

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NCT06256705


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