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Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications

NCT06121271 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-12-07

No results posted yet for this study

Summary

This study is a phase 2, open, single-site trial. The primary objective of this study is to prospectively evaluate the safety and efficacy in participants treated with Lu-177 DOTATATE (Lutathera) in unresectable or metastatic, somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications (eg, bronchial and thymic NET; paraganglioma/phaeochromocytoma; medullary thyroid carcinoma; and those requiring repeat peptide receptor radionuclide therapy (PRRT) with 2 further cycles of Lutathera). The aim is to recruit a total of 75-110 participants. Each patient will receive 4 cycles of Lutathera with 8-12 weeks time interval (except patients requiring repeat PRRT will receive 2 further cycles of Lutathera). The follow-up period will be for 2 years from the date of the last treatment.

Conditions

  • Bronchial and Thymic Neuroendocrine Tumour
  • Paraganglioma/ Phaeochromocytoma
  • Medullary Thyroid Carcinoma
  • Those Requiring Repeat Peptide Receptor Radionuclide Therapy

Interventions

DRUG

Lu-177 DOTATATE (Lutathera®)

Treatment with Lutathera will consist of a total cumulative intravenous (IV) administered radioactivity dose of 29.6 GBq (800 mCi) or 14.8 GBq (400 mCi) for 4 cycles or 2 cycles of Lutathera, respectively.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2027-11-06
Completion
2027-11-06

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Diseases

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 NCT06121271 on ClinicalTrials.gov