Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

Exclusion Criteria

• •Known hypersensitivity to edotreotide or everolimus
• •Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
• •Prior exposure to any peptide receptor radionuclide therapy (PRRT)
• •Prior therapy with mTor inhibitors
• •Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
• •Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
• •Indication for surgical lesion removal with curative potential
• •Planned alternative therapy (for the period of study participation)
• •Serious non-malignant disease
• •Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
• •Pregnant or breast-feeding women
• •Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).