Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ITM Solucin GmbH
With
ABX CRO
PSI CRO
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically 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
Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)
You may not be if
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.).
Clareo Health | Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
