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Diagnosis | Gastroenteropancreatic Neuroendocrine Tumors, Pheochromocytoma, Paraganglioma | Study Status | Open |
Phase | II |
Age | 12 to 17 Years Old | Randomisation | NO |
Line of treatment | Disease relapse or progression |
Routes of Treatment Administration | Drug: Lutetium [177Lu] oxodotreotide/dotatate (Other Name: Lutathera)
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
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Last Posted Update | 2024-06-21 |
ClinicalTrials.gov # | NCT04711135 |
International Sponsor
Advanced Accelerator ApplicationsPrincipal Investigators for Canadian Sites
CHU de Québec – Université Laval – Dr François-Alexandre ButeauCentres
Medical contact
Raoul Santiago
Social worker/patient navigator contact
Isabelle Audet
Clinical research contact
Barbara Desbiens
Study Description
This is a phase 2 study designed to evaluate the safety of a drug called Lutathera in patients 12 to <18 years old with GEP-NET and PPGL disease. For patients on the study, this drug will be infused 4 times at 8-week intervals. After the infusions are complete, a follow-up period will take place after the last dose for each patient who received at least one dose of Lutathera.
Inclusion Criteria
- Patients must have a diagnosis of GEP-NET or PPGL that has gotten worse or can not be operated on
- Patients must be between 12 to <18 years old at the time of enrollment
- Patients must be up and about for over half of their waking hours
- Patients and their families (as applicable) must agree to sign the written informed consent forms outlined by the study team
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.