TheranosticTrials.org

Clinical Trial · NCT06256705

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

Overview

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.

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

N/A

Contacts

Catherine ANSQUER (CONTACT)

catherine.ansquer@chu-nantes.fr

00-33-2-40-08-41-36

Louis DE MESTIER (CONTACT)

louis.demestier@aphp.fr

00-33-1-40-87-53-28

ClinicalTrials.gov

NCT06256705

Drug / Compound

DOTATOC

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • SSTR+ disease, as evidenced by PET-DOTATOC performed within 4 months prior to inclusion (lesion uptake greater than liver physiological uptake)
  • * 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

Exclusion

  • * Known pregnancy or breastfeeding women
  • Prior external beam radiation therapy (EBRT) of GEP-NET lesions or liver selective internal radiation therapy within 12 weeks before inclusion, if extensive
  • Known hypersensitivity to 177Lu, octreotate, DOTA, 68Ga, Edotreotide,
  • Contraindication to MRI and technical impossibility of MRI
  • Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective amino acid solution (AAS) given concomitantly to the 177Lu-DOTATATE infusion.