Status and phase
Conditions
Treatments
About
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:
This study also has a compassionate purpose, which is to provide access to PRRT to patients.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
275 participants in 1 patient group
Loading...
Central trial contact
Geneviève Filion; Jean-Mathieu Beauregard, MD,MSc,FRCPC
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal