Actively Recruiting
61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET)
Led by University Hospital, Basel, Switzerland · Updated on 2025-05-30
27
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 aged over 18 years of any gender
- Women of childbearing potential must have a negative pregnancy test
- Histologically confirmed well-differentiated bronchopulmonary or gastroenteropancreatic neuroendocrine tumors of any grade (including NET G3 with Ki-67 <30%)
- Clinical indication for somatostatin receptor PET/CT imaging for staging, restaging, treatment planning, patient selection for therapy, or treatment response assessment
- Standard 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 if 68Ga-DOTATOC PET/CT is negative, a positive NETest within 4 weeks in 5 additional patients
- Estimated glomerular filtration rate (eGFR) of at least 45 mL/min
- If applicable, last somatostatin analogue injection administered 2 weeks (+/- 1 week) before PET scan for long-acting forms
You will not qualify if you...
- Known allergy or hypersensitivity to 61Cu, NODAGA, LM3, or any components of 61Cu-NODAGA-LM3
- Prior or planned use of radiopharmaceuticals within 8 half-lives of the radionuclide used, including during this study
- Starting or continuing active anti-tumor treatments between 61Cu-NODAGA-LM3 and 68Ga-DOTATOC PET/CT, except continued long-acting somatostatin analogues
- Active infection at screening or serious infection within the past 6 weeks
- Pregnant or breastfeeding women
- History of physical or mental illness that could interfere with study objectives or assessments
AI-Screening
AI-Powered Screening
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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.
CONTACT
D
Damian Wild, Prof. Dr. Dr.
CONTACT
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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