drugset / Trial / NCT06455358

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

NCT06455358

Phase 1/2 Recruiting 27 enrolled University Hospital, Basel, Switzerland
RandomizedParallel-groupSingle-blindDiagnostic

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.

Timeline

Start
2025-02-05
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject 61Cu-NODAGA-LM3 Diagnostic / imaging agent 20 ug Intravenous
Subject 61Cu-NODAGA-LM3 Diagnostic / imaging agent 40 ug Intravenous
Subject 61Cu-NODAGA-LM3 Diagnostic / imaging agent 150 mbq Intravenous
Subject 68Ga-DOTATOC Peptide Intravenous