CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 11 enrolled
Drug / intervention
Lutetium [177Lu] oxodotreotide/dotatatedrug
Likely dose
Lutetium [177Lu] oxodotreotide/dotatate 30 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04711135
NCT04711135Phase 2Active

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)

Advanced Accelerator Applications·interventional·Posted Jan 15, 2021·Updated Feb 12, 2026

In Brief

A Phase 2 clinical trial evaluating Lutetium [177Lu] oxodotreotide/dotatate for Gastroenteropancreatic Neuroendocrine Tumors and 2 related conditions. Active but no longer recruiting, targeting 11 participants across 7 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2Active
20212022202320242025202620272028202920302031203220332034
First PostedJan 15, 2021
Enrollment StartAug 31, 2022
Primary CompletionMar 12, 2024
Study CompletionFeb 6, 2034
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.5 years ago

Interventions

Lutetium [177Lu] oxodotreotide/dotatatedrug

Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)