61Cu-NODAGA-LM3 for the detection of neuroendocrine tumours: Preliminary results of the COPPER PET in NET trial, a randomised, crossover, readers blind, phase I/II non-inferiority study

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Introduction: Currently approved PET tracers, Gallium-68 or Copper-64 labelled somatostatin receptor (SST) agonists (NETSPOT®, SOMAKIT® and Detecnet™), for imaging well-differentiated gastroenteropancreatic and bronchopulmonary neuroendocrine tumours (NET) have limitations. Radiolabelled SST antagonists offer superior imaging properties over agonists, and the combination with Copper-61, an unexplored PET isotope with a 3.33-hour half-life and favourable production characteristics, could be promising.

Aim(s): To assess the safety, biodistribution, dosimetry, diagnostic efficacy, and impact on management of [61Cu]Cu-NODAGA-LM3 PET/CT in well-differentiated SST-positive gastroenteropancreatic and bronchopulmonary NETs.

Materials and methods: This first-in-human phase I/II study is a prospective, open-label, randomised, crossover-controlled, readers-blind trial, at a single centre involving 22 patients to evaluate safety and non-inferior sensitivity of [61Cu]Cu-NODAGA-LM3 compared to [68Ga]Ga-DOTA-TOC PET/CT as co-primary endpoints. Biopsy or 2- to 7-month follow-up imaging (including liver MRI, contrast-enhanced CT and/or SST PET/CT) will serve as the gold standard. Impact on management will be assessed by a multidisciplinary board.

Conference:

Presenting Author: Nicolas G

Authors: Nicolas G, Chirindel A, Kaul F, Rommers N, Johayem A,

Keywords: Somatostatin Receptor PET/CT, Well-differentiated NEN, gastroenteropancreatic NET, bronchopulmonary NET, randomised controlled clinical trial, somatostatin receptor antagonist,