NCT02754297

Personalized PRRT of Neuroendocrine Tumors

Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs. The purpose of this study is to: * Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT; * Assess the overall, the disease-specific, and the progression-free survival following P-PRRT; * Correlate therapeutic response and survival with tumor absorbed radiation dose; * Evaluate the acute, subacute and chronic adverse events following P-PRRT; * Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk; * Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research). This study also has a compassionate purpose, which is to provide access to PRRT to patients.

Detailed description

A prospective, single-center, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumors (NET) of any origin expressing the somatostatin receptor. The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for at least the first 85 participants. This study as a compassionate aim to provide access to personalized PRRT patients at CHU de Québec - Université Laval center, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim. The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.

Conditions

• Neuroendocrine Tumors
• Carcinoid Tumor
• Carcinoma, Neuroendocrine

Interventions

Type	Name	Description
DRUG	177Lu-Octreotate	* The induction course will consist in 4 cycles at 8-10 weeks intervals. * Concomitant amino acids will be administered for renal protection. * Intra-arterial LuTate administration will be allowed in suitable cases. * Dosimetry will be based on quantitative SPECT/CT imaging. * In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles.

Timeline

• Start date: 2016-04-12
• Primary completion: 2025-04-12
• Completion: 2029-04-12
• First posted: 2016-04-28
• Last updated: 2024-08-21

Locations

1 site across 1 country: Canada