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ACTIVE NOT RECRUITING
NCT04711135
PHASE2

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs

Sponsor: Advanced Accelerator Applications

View on ClinicalTrials.gov

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

DRUG

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