Not Yet RecruitingPhase 2

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

110 participantsStarted 2023-12-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Confirmed presence of somatostatin receptors on all target lesions (for target/non-target/measurable lesions definition see RECIST Criteria, Version 1.1) documented by CT/MRI scans, based on positive OctreoScan or Ga68 Dotatate PET imaging within 24 weeks prior to enrolment in the trial.
✓. The tumour uptake observed in each target lesion (for target/non-target/measurable lesions definition see RECIST Criteria, Version 1.1) using OctreoScan/Tc-99m-SRS should be ≥ normal liver uptake observed on planar imaging.
✓. The tumour uptake observed in each target lesion (for target/non-target/ measurable lesions definition see RECIST Criteria, Version 1.1) using Ga68 Dotatate PET should be ≥ normal liver uptake observed on PET imaging.

What they're measuring

To prospectively evaluate safety in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications

Timeframe: 4 years

To prospectively evaluate tolerability in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications

Timeframe: 4 years

To prospectively evaluate efficacy in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor expressing neuroendocrine tumours (NET) in currently unlicensed indications

Timeframe: 4 years

Trial details

NCT IDNCT06121271

SponsorUniversity College, London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-06

Contact for this trial

Martyn Caplin, Prof.

020 3758 2000 m.caplin@ucl.ac.uk

View on ClinicalTrials.gov More Bronchial and Thymic Neuroendocrine Tumour trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Confirmed presence of somatostatin receptors on all target lesions (for target/non-target/measurable lesions definition see RECIST Criteria, Version 1.1) documented by CT/MRI scans, based on positive OctreoScan or Ga68 Dotatate PET imaging within 24 weeks prior to enrolment in the trial.
✓. The tumour uptake observed in each target lesion (for target/non-target/measurable lesions definition see RECIST Criteria, Version 1.1) using OctreoScan/Tc-99m-SRS should be ≥ normal liver uptake observed on planar imaging.
✓. The tumour uptake observed in each target lesion (for target/non-target/ measurable lesions definition see RECIST Criteria, Version 1.1) using Ga68 Dotatate PET should be ≥ normal liver uptake observed on PET imaging.

What they're measuring

To prospectively evaluate safety in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications

Timeframe: 4 years

To prospectively evaluate tolerability in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor-expressing neuroendocrine tumours (NET) in currently unlicensed indications

Timeframe: 4 years

To prospectively evaluate efficacy in participants treated with Lu-177 DOTATATE (Lutathera) in somatostatin receptor expressing neuroendocrine tumours (NET) in currently unlicensed indications

Timeframe: 4 years

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria