NCT06455358Recruiting
61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET)
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1 · Phase 2
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- University Hospital, Basel, Switzerland(Other)
- Protocol no.
- 2023-01981; th22Nicolas
- Conditions
- Neuroendocrine Tumors
- Interventions
- Drug, Other
Treatments studied
- 61Cu-NODAGA-LM3
- Comparator
Locations · 1
- Basel, SwitzerlandUniversity Hospital Basel, Department of Radiology and Nuclear MedicineRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: May 30, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
Other identifiers
- 2023 · NIH grant
See also
Other versions
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