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ACTIVE NOT RECRUITING
NCT02754297
PHASE2

Personalized PRRT of Neuroendocrine Tumors

Sponsor: CHU de Quebec-Universite Laval

View on ClinicalTrials.gov

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.

Official title: Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

275

Start Date

2016-04-12

Completion Date

2029-04-12

Last Updated

2024-08-21

Healthy Volunteers

No

Interventions

DRUG

177Lu-Octreotate

* The induction course will consist in 4 cycles at 8-10 weeks intervals. * Concomitant amino acids will be administered for renal protection. * Intra-arterial LuTate administration will be allowed in suitable cases. * Dosimetry will be based on quantitative SPECT/CT imaging. * In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles.

Locations (1)

CHU de Québec - Université Laval

Québec, Quebec, Canada