* Safety & dosimetry of Lutathera in adolescents with GEP-NETs and PPGLs
Research type
Research Study
Full title
A multicenter open label study to evaluate safety and dosimetry of Lutathera in adolescent patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NETs) tumours, pheochromocytoma and paragangliomas
IRAS ID
290884
Contact name
Mark Nicholas Gaze
Contact email
Sponsor organisation
Advanced Accelerator Applications, a Novartis Company
Eudract number
2020-002951-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 4 months, 17 days
Research summary
The main purpose of the NETTER-P study is to determine whether the use of Lutathera is safe in adolescent patients with gastro-entero-pancreatic neuroendocrine tumours (GEP-NET), pheochromocytoma and paragangliomas (PPGL) and to evaluate the radioactivity after the Lutathera administration. Lutathera is a drug that can attach to tumour cells the same way as a hormone somatostatin. It carries radioactive element, which can deliver strong radiation directly to the tumour cells. Lutathera is approved in the UK for adult patients with GEP-NET. In this study Lutathera will be given to adolescent patients with tumours that have spread in the body (metastasized) and cannot be removed surgically. At least 8 adolescents from 12 to 17 years old with GEP-NETs will be enrolled, additionally, the study will also be open for the recruitment of adolescents with PPGL. Patients will be enrolled for a treatment period of 6 months to receive 4 Lutathera infusions administered at 8-week intervals, and then will be followed up for 5 years. During the study, patients will undergo physical exams, vital signs and ECG measurements, radioactivity measurements, blood and urine tests, and scans for tumour assessment. Due to limitations in approved therapies for GEP-NETs and PPGL in the paediatric population, this study aims to address this unmet need and to accelerate the access of Lutathera as a potential treatment for adolescent patients with GEP-NETs and PPGLs.
REC name
London - Westminster Research Ethics Committee
REC reference
21/FT/0018
Date of REC Opinion
1 Apr 2021
REC opinion
Further Information Favourable Opinion