Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications
Research type
Research Study
Full title
Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications Including Bronchial and Thymic Neuroendocrine Tumour, Paraganglioma/ Phaeochromocytoma, Medullary Thyroid Carcinoma, and Those Requiring Repeat Peptide Receptor Radionuclide Therapy (Phase 2 trial)
IRAS ID
296162
Contact name
Martyn Caplin
Contact email
Sponsor organisation
University College London (UCL)
Eudract number
2021-002925-12
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This study is a phase 2, open, single-site trial. The primary objective of this study is to prospectively evaluate 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.REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0906
Date of REC Opinion
20 Jan 2022
REC opinion
Further Information Favourable Opinion