NCT06121271

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

Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications Including Bronchial and Thymic Neuroendocrine Tumour, Paraganglioma/Phaeochromocytoma, Medullary Thyroid Carcinoma, and Repeat Peptide Receptor Radionuclide Therapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This clinical study is being conducted at the Royal Free Hospital / London. A total of 75-110 participants will be enrolled based on multidisciplinary team decisions and after meeting the criteria for enrollment. Patients involved will be classified into the following subgroups: Repeat PRRT if the participant have had the PRRT treatment before (2 cycles each): 35-45 participants Bronchial NET (4 cycles each): 25-35 participants Paraganglioma or phaeochromocytopma (4 cycles each): 10-20 participants Others NETs (eg, MedullaryThyroid Carcinoma) (4 cycles each): 5-10 participants The duration of study participation for all patients will be 24 months. After the participant signed the Informed Consent Form, he/she will be asked to undergo several screening investigations and procedures to ensure they are appropriate for the treatment and study. The screening takes place between 90 days and 1 day before treatment. Screening evaluations will include a review of the previous scans and blood tests. It is possible that in this period the participant might need an additional scan or blood test to ensure the participant meets the requirements of the study. During visits, the research doctor or nurse will take a relevant medical history and perform a physical exam and check the vital signs. The participant will be asked to fill a Quality-of-Life questionnaire. Then blood and urine samples will be taken from the participant and will be sent to the laboratory for analysis. The participant will also be sent for a scan to assess heart function. Treatment Phase: Therapy Visits (Week 0,8,16,24): The participant will be interviewed by the research doctor /nurse and will be asked few questions related to cancer and general health. A blood sample will be taken and sent for analysis. The radiopeptide 177Lu-DOTATATE will be administered as a slow intravenous infusion via a cannula into a vein in the arm. The infusion will last 20 to 30 minutes. In addition to the 177Lu-DOTATATE administration, the participant will receive an amino acid solution (AAS) which is given to protect kidneys from radiation. The amino acid solution is infused over 4 - 6 hours, starting 30 - 60 minutes before PRRT via the same cannula. After infusion of 177Lu-DOTATATE, the participant's vital signs (temperature, pulse and blood pressure) will be checked. Around 4 hours after each therapy administration the participant will have imaging with a scan in the nuclear medicine department to show that the tumour has taken up the treatment as expected. After 177Lu-DOTATATE the participant will receive a patient card with safety precautions to be taken after being administered the radioactive therapy. Post Therapy Visits (Week 4,12,20,28, and week 36) (performed at local GP or nurse at home). A blood test will be taken to check that blood cells are in an appropriate range and that kidney function is at the recommended levels. Follow-Up phase: After completion of the 24 months, the participant will return to that usual protocol of CT or MRI scans every 6 months. The participant will meet the study doctor/nurse as usual who will perform an examination and arrange the standard blood tests. The trial will be finished after 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

Type	Name	Description
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.

Timeline

• Start date: 2023-12-18
• Primary completion: 2027-11-06
• Completion: 2027-11-06
• First posted: 2023-11-07
• Last updated: 2023-12-07