Personalized PRRT of Neuroendocrine Tumors

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Québec, CHU de Québec; CHU de Quebec-Universite Laval
• Treatments: Lutetium Lu 177 dotatate

Criteria

Inclusion Criteria:

• Patient suffering from a progressive and/or symptomatic NET (any site);

• Patient ineligible to, or refusing a potentially curative treatment such as surgical resection;

• Patient who did not respond, is intolerant or refuses other indicated and available palliative treatments;

• Demonstration of overexpression of somatostatin receptor by tumor lesions by scintigraphic imaging (Octreoscan or 68Ga positron emission tomography.

Exclusion Criteria:

• Pregnancy;

• Breastfeeding;.

• Very limited survival prognosis (i.e. less than a few weeks, because of the NET disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4 performance status;

• Inability to obtain informed consent of the participant.