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Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs
Sponsor: Advanced Accelerator Applications
Summary
This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to \<18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.
Official title: A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2022-08-31
Completion Date
2034-02-06
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Locations (7)
University of Kentucky
Lexington, Kentucky, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Centre Léon Berard
Lyon, France
Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, Poland
Hospital Universitari Vall d'Hebron
Barcelona, Spain
University College Hospital of London
London, United Kingdom