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

Korábbi kezelés

• Prior external beam radiation therapy (EBRT) of GEP-NET lesions or liver selective internal radiation therapy within 12 weeks before inclusion, if extensive
• 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
• Prior peptide receptor radionuclide therapy (PRRT)

Más betegség

• 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.
• NYHA 3 or 4 heart failure
• Other progressive cancer excluding in situ cervical cancer and basal or squamous cell skin cancer within the last 3 years

Laborértékek

• 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

Egyéb

• Known pregnancy or breastfeeding women
• 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
• 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

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