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

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial, called COPPER PET in NET, is studying a new imaging test using a substance called 61Cu-NODAGA-LM3 to see how well it detects neuroendocrine tumors compared to the standard test, 68Ga-DOTATOC. Neuroendocrine tumors are a type of cancer that can occur in organs like the lungs and pancreas. The trial aims to find out if the new test is safe and if it works better at spotting these tumors.

To participate in this study, you need to be 18 years or older and have a confirmed diagnosis of well-differentiated neuroendocrine tumors. Women who can become pregnant must have a negative pregnancy test. You should also have a recent scan that shows at least three tumors or positive test results. If you join the trial, you will receive the new imaging test and then undergo the standard imaging within a few weeks. The study is currently looking for participants, and it’s important to know that there are certain health conditions that may prevent someone from joining, like allergies to the test substances or active infections.

Gender

ALL

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