61cu-nodaga-lm3 pet/ct for the detection of neuroendocrine tumors (copper pet in net)

Conditions: Neuroendocrine Tumors

Summary: the goal of this monocentric, open-label, randomized-controlled, reader-blind clinical study is to assess the safety of the radiolabeled somatostatin receptor ligand, 61cu-nodaga-lm3, and its sensitivity in comparison to the standard of care, 68ga-dotatoc, for pet/ct imaging in patients with well differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors.

neuroendocrine tumors (net) originate from neuroendocrine cells and are most commonly found in the gastro-intestinal tract, pancreas and lung. many net grow slowly and are asymptomatic, leading to up to 50% being metastatic at diagnosis. overexpression of somatostatin receptor subtype 2 (sst2) is a characteristic of net and presents an important molecular target for the management of these tumors. in switzerland, two radiolabeled somatostatin analogues, gallium-68-labeled (68ga)-dotatoc and 68ga-dotatate, are used for sst pet/ct imaging of well-differentiated neuroendocrine tumors. while these radiolabeled sst agonists provide high clinical performance and can be locally produced, they face limitations such as high costs, limited production capacity, short half-life hindering shipment to smaller centers, and high physiological uptake in organs like the liver, complicating tumor detection. a novel copper-61 (61cu) labeled somatostatin receptor antagonist, 61cu-nodaga-lm3, shows promise as an imaging agent for sst2 expressing tumors. it offers a longer half-life, enhanced tumor uptake and retention compared to established radiolabeled sst agonists, and improves image contrast. this study aims to compare the safety and sensitivity of 61cu-nodaga-lm3 to the standard of care, 68ga-dotatoc, for sst pet/ct imaging in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors. the results of the study potentially lead to enhanced diagnostic accuracy and patient care in the management of neuroendocrine tumors.

Eligibility criteria:
inclusion criteria: * written informed consent signed * \>18 years old patients of either gender * for women in child-bearing age: a negative pregnancy test is required * histologically proven well-differentiated bronchopulmonary (typical or atypical carcinoid) or gastroenteropancreatic neuroendocrine tumors (net) of all grade (including net g3 with ki-67 \<30 %) * clinical indication to somatostatin receptor (sst) pet/ct imaging for either primary staging, restaging, patient selection to peptide receptor radionuclide therapy, treatment planning or treatment response assessment * standard of care 68ga-dotatoc pet/ct performed or planned within max. 4 weeks prior or after imp-administration, as clinically indicated * at least 3 lesions detected by the previous somatostatin receptor scan, or if 68ga-dotatoc pet/ct is negative, a positive netest not older than 4 weeks should be available in 5 additional patients * estimated egfr (ckd-epi) ≥ 45 ml/min * if applicable, the last regular somatostatin analogue injection should be administered 2 weeks +/- 1 week prior to sst pet scan for long acting release forms exclusion criteria: * known hypersensitivity to 61cu, to nodaga, to lm3 or to any of the excipients of 61cu-nodaga-lm3 * prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study * initiation or continuation of active anti-tumor treatment between 61cu-nodaga-lm3 and 68ga-dotatoc pet/ct, except continuation of long acting somatostatin analogues * presence of active infection at screening or history of serious infection within the previous 6 weeks * pregnant or breast-feeding women * history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

Keywords: radiolabeled somatostatin receptor ligands sst pet/ct imaging somatostatin receptor subtype 2 (sst2) tumor detection