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

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.

Timeline

Start

2022-08-31

Primary completion

2024-03-12

Completion

2034-02-06

Publications

• Gaze MN, Handkiewicz-Junak D, Hladun R, Laetsch TW, Sorge C, Sparks R, Wan S, Ceraulo A, Kluczewska-Galka A, Gamez-Cenzano C, States LJ, El Khouli R, Aimone P, Perraud K, Kollar G, Khanshan F, Blumenstein L, Brouri F, Giraudet AL. Safety and dosimetry of [177Lu]Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, or pheochromocytomas and paragangliomas: Primary analysis of the Phase II NETTER-P study. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4001-4015. doi: 10.1007/s00259-025-07246-7. Epub 2025 Apr 8.

Drugs

Indications