Study of 61Cu-NODAGA-LM3 PETCT Compared to 68Ga-DOTATOC for Detecting Neuroendocrine Tumors A Phase III Randomized, Open-label Single Center Trial

What this Trial Is About

Researchers are evaluating the safety and sensitivity of a new imaging agent called 61Cu-NODAGA-LM3 compared to the standard 68Ga-DOTATOC for PETCT scans in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors NET. These tumors arise from neuroendocrine cells, often grow slowly, and may be metastatic at diagnosis. The study aims to improve diagnostic accuracy using this novel radiolabeled somatostatin receptor antagonist, which may offer advantages such as longer half-life and better tumor imaging contrast. Participants will receive a single intravenous dose of 61Cu-NODAGA-LM3 followed by up to three PETCT scans. They will be randomly assigned to have the 61Cu-NODAGA-LM3 PETCT either before or after their routine 68Ga-DOTATOC PETCT, which is part of standard care. This open-label, randomized, controlled study takes place at one center and compares these two imaging approaches within a 24-hour to 4-week window. During the study, safety is monitored by tracking adverse events up to 18 hours after injection. Researchers will assess the sensitivity of 61Cu-NODAGA-LM3 imaging one hour after injection and evaluate various measures including tumor uptake, biodistribution, and patient preferences. Blood samples will be collected at multiple time points to study drug concentration and clearance. The total study duration spans from baseline assessments through imaging and follow-up, helping to understand the potential of 61Cu-NODAGA-LM3 in managing neuroendocrine tumors.

61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET)