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Personalized PRRT of Neuroendocrine Tumors

Study acronym: P-PRRT
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 300 to confirmed 275
    • Site details revised
    v7
  2. Primary completion date: Apr 2021 to Apr 12, 2025
    • Study completion date: Dec 2026 to Apr 12, 2029
    v6
  3. Enrollment target: 85 to 300
    • Start date: Apr 2016 to Apr 12, 2016
    • Study description expanded, about 3 words
    v5
  4. 2 versions Re-verified since Feb 1, 2017, no change to tracked fieldsv3-v4
  5. Site contact updatedv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02754297
Lead Sponsor CHU de Quebec-Universite Laval
Conditions
(from sponsor)		 Neuroendocrine Tumors, Carcinoid Tumor, Carcinoma, Neuroendocrine
Related terms Carcinoid Tumor, Carcinoma, Neuroendocrine, Neuroendocrine Tumors
Enrollment 275 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov