Personalized PRRT of Neuroendocrine Tumors

  • STATUS
    Recruiting
  • End date
    Dec 24, 2026
  • participants needed
    300
  • sponsor
    CHU de Quebec-Universite Laval
Updated on 24 January 2021
somatostatin
pet scan
positron emission tomography
SPECT Scan
neuroendocrine tumor
radionuclide therapy
177lu-octreotate
peptide receptor radionuclide therapy

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.

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 Qubec - Universit 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.

Details
Condition Neuroendocrine Tumor, Adenocarcinoma, Neuroectodermal Tumor, Neuroendocrine carcinoma, Carcinoid Tumor, Neurectoderma, Malignant Adenoma, carcinoid, neuroendocrine tumors, neuroendocrine tumour
Treatment 177Lu-Octreotate
Clinical Study IdentifierNCT02754297
SponsorCHU de Quebec-Universite Laval
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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