Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications
Status:
Not yet recruiting
Trial end date:
2027-11-06
Target enrollment:
Participant gender:
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.