NCT06455358 61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET)
| NCT ID | NCT06455358 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Neuroendocrine Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2025-02-05 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Guillaume Nicolas, Dr.
PRINCIPAL INVESTIGATOR
Division of Nuclear Medicine, University Hospital Basel
Frequently Asked Questions
Who can join the NCT06455358 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuroendocrine Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06455358 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06455358 currently recruiting?
Yes, NCT06455358 is actively recruiting participants. Contact the research team at guillaume.nicolas@usb.ch for enrollment information.
Where is the NCT06455358 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06455358 clinical trial?
NCT06455358 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Guillaume Nicolas, Dr. at Division of Nuclear Medicine, University Hospital Basel. The trial plans to enroll 27 participants.