Last updated on December 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neuroendocrine Tumor
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Histologically and clinically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
  • Measurable disease per RECIST 1.1
  • Somatostatin receptor positive (SSTR+) disease
  • Radiological disease progression, defined as progressive disease per RECIST 1.1. criteria

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 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
  • 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.).

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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