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A Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.

NCT03966651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-04-29

No results posted yet for this study

Summary

This study is a multicenter, open label phase I dose escalation trial designed to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE in children with refractory or recurrent neuroblastoma.

177Lu-DOTATATE will be delivered intravenously for 2 cycles, 6 weeks apart.

The duration of study participation of each patient will be 5 months.

Conditions

Interventions

DRUG

PRRT with 177Lu-DOTATATE

Children will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2024-08-08
Completion
2024-08-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

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 NCT03966651 on ClinicalTrials.gov