Actively Recruiting
61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors: The COPPER PET in NET Study A Prospective, Open-label, Randomized, Controlled, Single Centre, Phase I/II PET/CT Study
Led by University Hospital, Basel, Switzerland · Updated on 2025-05-30
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 PET/CT 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 PET/CT scans. They will be randomly assigned to have the 61Cu-NODAGA-LM3 PET/CT either before or after their routine 68Ga-DOTATOC PET/CT, 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo PET/CT imaging with 61Cu-NODAGA-LM3 and 68Ga-DOTATOC to detect neuroendocrine tumors and assess diagnostic sensitivity and safety.
1 to 2 visits depending on the timing of PET/CT scans
Trial Site Locations
Total: 1 location
1
University Hospital Basel, Department of Radiology and Nuclear Medicine
Basel, Canton of Basel-City, Switzerland, 4031
Actively Recruiting
Research Team
G
Guillaume Nicolas, Dr.
D
Damian Wild, Prof. Dr. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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