Personalized PRRT of Neuroendocrine Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Objective response rate (ORR) — 3 months after induction course
  Primary efficacy endpoint is the objective response rate on contrast-enhanced CT (or MRI) by RECIST criteria (and secondarily by South Western Oncology Group (SWOG) criteria) at 3 months after the 4th induction cycle of P-PRRT, in comparison to pre-treatment scan (within 3 months before commencing P-PRRT).

Trial sites (1)

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