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

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

Inclusion Criteria:

* According the MDT decision to refer to PRRT

  1. Histologically confirmed diagnosis of unresectable GEP-NETs whatever the grade or NETs of unknown primary but suspected of GEP origin
  2. Metastastic and progressive according RECIST 1.1 criteria
  3. At least 1 measurable site of disease per RECIST v1.1 using contrast-enhanced CT or magnetic resonance imaging
  4. SSTR+ disease, as evidenced by PET-DOTATOC performed within 4 months prior to inclusion (lesion uptake greater than liver physiological uptake)
  5. 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

Exclusion Criteria:

* 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
* Prior external beam radiation therapy (EBRT) of GEP-NET lesions or liver selective internal radiation therapy within 12 weeks before inclusion, if extensive
* 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
  * Prothrombin time \< 70% unless albumin \> 30g/L
  * Albumin \<30g/L unless prothrombin time \> 70 %
  * Glomerular Filtration Rate (GFR) \< 35 mL/min/1.73 m2
* Prior peptide receptor radionuclide therapy (PRRT)
* Other progressive cancer excluding in situ cervical cancer and basal or squamous cell skin cancer within the last 3 years
* Patient refusal to give written informed consent
* Subject deprived of freedom, subject under a legal protective measure
* No affiliation to a social security regimen or CMU
* Patient under State Medical Aid

Conditions3

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