MedTrace Logo

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

NCT04711135 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-02-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Gastroenteropancreatic Neuroendocrine Tumors
  • Pheochromocytoma
  • Paraganglioma

Interventions

DRUG

Lutetium [177Lu] oxodotreotide/dotatate

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

Sponsors & Collaborators

  • Advanced Accelerator Applications

    lead INDUSTRY

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-03-12
Completion
2034-02-06
FDA Drug
Yes

Countries

  • United States
  • France
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04711135 on ClinicalTrials.gov