Personalized PRRT of Neuroendocrine Tumors — P-PRRT  

Neuroendocrine Tumors Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Neuroendocrine
• Neoplasms
• Neuroendocrine Tumors

• NCT number: NCT02754297
• Study type: Interventional
• Source: CHU de Quebec-Universite Laval
• Contact: Jean-Mathieu Beauregard, MD,MSc,FRCPC
• Phone: 418-525-4444
• Email: medecine.nucleaire@mail.chudequebec.ca
• Status: Recruiting
• Phase: Phase 2
• Start date: April 12, 2016
• Completion date: April 12, 2029