Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults MedDRA version: 20.0 Level: LLT Classification code 10077560 Term: Gastroenteropancreatic neuroendocrine tumor disease System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Lutathera 370 MBq/mL solution for infusion
Product Name: Lutathera 370 MBq/mL solution for infusion
Pharmaceutical Form: Solution for infusion
Trade Name: SomaKit TOC 40 micrograms kit fo
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically proven well differentiated neuroendocrine tumor (NET) of gastrointestinal or pancreatic origin (GEP). • Liver Metastatic disease dominant or exclusive and not amenable to surgical resection • Patients are progressive after treatment with cold somatostatin analogue (within 12 months according to RECIST) • Patient has received 4 standard of care LUTATHERA® cycles • ECOG performance status 0-2 • Adequate kidney and liver function: creatinine clearance = 50 mL/min, ALT/AST = 2,5x the upper limit of normal • With no evidence of hematologic alteration after 4 LUTATHERA® cycles: hemoglobin = 8 g/dL, neutrophils = 1500/ mm3, platelets = 100.000/mm3 • Age = 18 years, no superior limit • Contraception required in pre-menopausal female during and for 6 months post-treatment. • Patient´s signed written informed consent • Patient affiliated to a social security system Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Carcinoid heart disease (LVEF < 40%) • Dominant or threatening extrahepatic metastases or that may affect vital prognosis • Contraindications to intra-hepatic arterial infusion (coagulation disorders, portal thrombosis, intra-hepatic biliary tract dilatation, digestive or biliary anastomosis or fistula, cirrhosis (Child Pugh B8 or C…) • Serum albumin <3.0 g/dL unless prothrombin time is within the normal range. • Heart failure, myocardial infarction, stroke, uncontrolled arterial hypertension under optimal treatment (= 160/95 mmHg), pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months. • Pregnancy or breast feeding • Currently participating to another clinical research protocol • Individuals under legal protection or unable of giving their informed consent • MRI scan contraindicated • LUTATHERA® contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 68Ga-DOTA-peptides uptake (SUVmax) in 5 liver metastases on PET-scan obtained after intra-hepatic radiolabeled somatostatin analogs (SSA) infusion and on PET-scan obtained after intravenous radiolabeled SSA administration;Secondary Objective: -Safety profile for sub-group : safety of 177Lu-DOTA-peptide after intra-arterial hepatic administration -68Ga-DOTA-peptide uptake (SUVmax) on dose limiting organs (kidney, spleen, healthy liver, bone marrow) after 68Ga-DOTA-peptides by arterial intrahepatic and intravenous injections -68Ga-DOTA-peptide uptake (SUVmax) on extra-hepatic lesion after 68Ga-DOTA-peptides by arterial intrahepatic and intravenous injections -For the sub-group : estimate the lesional and organ (kidney, spleen, healthy liver, bone marrow) absorbed doses after 177Lu-DOTA-peptide administration by intra-arterial hepatic and intravenous injections -For the sub-group : Efficacy evaluation of the fifth cycle of 177Lu-DOTA-peptide radiolabelled SSA therapy administered by intra-arterial hepatic infusion ;Primary end point(s): 68Ga-DOTA-peptides uptake (Maximum Standardized Uptake Value) in 5 liver metastases on PET-scan obtained after intra-hepatic injection;Timepoint(s) of evaluation of this end point: Visit 1 (inclusion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 68Ga-DOTA-peptides uptake (Maximum Standardized Uptake Value) in 5 liver metastases on PET-scan obtained after intravenous injection;Timepoint(s) of evaluation of this end point: Visit 2 | — |
Countries
France
Contacts
Public ContactLeila Boukami
CHU de Bordeaux
Outcome results
None listed