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.
Patients ≥18 years of age.
Participants capable of giving informed consent
Presence of unresectable or metastatic, well differentiated, somatostatin receptor positive non gastroenteropancreatic neuroendocrine tumours. Or for those having 2 cycles repeat therapy, GEP NET > 18 months from start of previous PRRT.
Patients must have progressive disease based on RECIST Criteria, Version 1.1. In order to make the assessment, two CT (or MRI) scans are required. The oldest scan must not be older than 3 years from the date of enrolment. The most recent scan must not be older than 6 weeks from the date of enrolment.
Participants will not be eligible for trial participation if they meet any of the exclusion criteria, or will be discontinued at the discretion of the Investigator if they develop any of the exclusion criteria during the trial.
Either serum creatinine >150 μmol/L (>1.7 mg/dL), or calculated creatinine clearance <40 mL/min, eventually confirmed by measured creatinine clearance (or measured GFR using isotopic GFR measurement) <40 mL/min (the measured creatinine clearance/GFR is required only as confirmatory exam).
Haemoglobin concentration <5.0 mmol/L (<8.0 g/dL); WBC <2 x109/L (2000/mm3); platelets <75 x109/L (75 x103/mm3).
Total bilirubin >3x upper limit of normal (ULN).