Last updated on March 2019

An Open Label Registry Study of Lutetium-177 (DOTA0 TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours

Brief description of study

Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as being effective in controlling symptoms and increase quality of life; induce stable disease and extend progression free survival; induce a (good) partial remission and induce a complete remission in patients with a somatostatin receptor positive tumour.

The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE, and the quality of life of the patients treated with Lu-DOTA-TATE.

Detailed Study Description

Neuroendocrine (NET) tumours have secretory and metabolic pathways not typically found in other cancers that can be utilized for molecular imaging and therapeutic targeting. The most important is somatostatin. Somatostatin receptors are useful tools in the diagnosis and treatment of NET tumours because the somatostatin analogue octreotate can be radiolabeled with lutetium-177 for imaging and therapy.

In selected populations of patients, radioisotope therapy in expert hands has been shown to be a safe and effective palliative therapy with stable disease, progression free survival benefit, symptom control and improvements in quality of life. Lutetium-177 (DOTA0, Tyr3) octreotate has been used in a significant number of clinical studies shown to be safe and effective as a therapeutic agent in patients with NET tumours. The investigators intend to further confirm these benefits with lutetium-177 octreotate, which could form the basis for a national registry study leading to registration of this therapeutic intervention.

Clinical Study Identifier: NCT02236910

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Recruitment Status: Open

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