What is 61Cu-NODAGA-LM3 studying for neuroendocrine tumors?

61Cu-NODAGA-LM3 is being studied to see how safely and accurately it can image neuroendocrine tumors compared to the standard 68Ga-DOTATOC scan. This study helps improve diagnosis and management of these tumors by assessing this new imaging agent. The research is led by the University Hospital in Basel, Switzerland.

Who may be eligible for this neuroendocrine tumor clinical trial?

Adults aged 18 years or older with well-differentiated bronchopulmonary or gastroenteropancreatic neuroendocrine tumors may be eligible. Both men and women can participate, but women of childbearing age need a negative pregnancy test. Participants should have normal kidney function and no recent serious infections. Please review eligibility criteria for more details.

Is there any cost to participate in this neuroendocrine tumor clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive the imaging and tests required by the trial without charge.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06455358

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

Led by University Hospital, Basel, Switzerland · Updated on 2025-05-30

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed written informed consent
Patients older than 18 years of any gender
Negative pregnancy test for women of child-bearing age
Histologically proven well-differentiated bronchopulmonary (typical or atypical carcinoid) or gastroenteropancreatic neuroendocrine tumors of all grades including NET G3 with Ki-67 less than 30%
Clinical indication for somatostatin receptor PET/CT imaging for staging, restaging, treatment planning, or response assessment
Standard care 68Ga-DOTATOC PET/CT performed or planned within 4 weeks before or after investigational medicinal product administration
At least 3 lesions detected by previous somatostatin receptor scan or positive NETest within 4 weeks if 68Ga-DOTATOC PET/CT is negative in 5 additional patients
Estimated glomerular filtration rate (eGFR) of 45 mL/min or higher
Last regular somatostatin analogue injection given 2 weeks plus or minus 1 week before PET scan for long-acting forms

You will not qualify if you...

Known allergy to 61Cu, NODAGA, LM3, or any components of 61Cu-NODAGA-LM3
Prior or planned radiopharmaceutical administration within 8 half-lives of radionuclide used, including during this study
Starting or continuing active anti-tumor treatment between 61Cu-NODAGA-LM3 and 68Ga-DOTATOC PET/CT except continuing long-acting somatostatin analogues
Active infection at screening or serious infection within the past 6 weeks
Pregnant or breastfeeding women
Somatic or psychiatric disease that could interfere with study objectives or assessments

Research Team

Guillaume Nicolas, Dr.

Damian Wild, Prof. Dr. Dr.

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