Clinical Trial

Personalized PRRT of Neuroendocrine Tumors

Study acronym: P-PRRT
Active, Not Recruiting Phase 2
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Record status
This record was last updated August 21, 2024 (before its estimated April 12, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2016-04-25; most recent amendment 2024-08-20.
Status change: Recruiting → Active, Not Recruiting 2024-08-20
Trial Details
NCT Number NCT02754297
Lead Sponsor CHU de Quebec-Universite Laval
Conditions Neuroendocrine Tumors, Carcinoid Tumor, Carcinoma, Neuroendocrine
Enrollment 275 participants
Start Date 2016-04-12
Primary Completion 2025-04-12 (estimated)
Study Completion 2029-04-12 (estimated)
Updated on ClinicalTrials.gov 2024-08-21