Using a new imaging agent to detect neuroendocrine tumors
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
PHASE1; PHASE2 · University Hospital, Basel, Switzerland · NCT06455358
This study is testing a new imaging agent to see if it can better detect neuroendocrine tumors in patients compared to the current standard method.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT06455358 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a novel radiolabeled somatostatin receptor antagonist, 61Cu-NODAGA-LM3, for PET/CT imaging in patients with well-differentiated neuroendocrine tumors. The study compares this new agent to the standard imaging method, 68Ga-DOTATOC, to determine its sensitivity and potential advantages in tumor detection. Participants will undergo imaging to assess the performance of 61Cu-NODAGA-LM3, which is expected to provide better image contrast and longer retention in tumors. The trial is conducted at the University Hospital Basel in Switzerland.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed well-differentiated bronchopulmonary or gastroenteropancreatic neuroendocrine tumors requiring PET/CT imaging.
Not a fit: Patients with poorly differentiated neuroendocrine tumors or those not requiring somatostatin receptor imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of neuroendocrine tumors, enhancing patient outcomes.
How similar studies have performed: While the use of radiolabeled somatostatin analogues is established, the specific application of 61Cu-NODAGA-LM3 for this purpose is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel, Canton of Basel-City
- University Hospital Basel, Department of Radiology and Nuclear Medicine — Basel, Canton of Basel-City, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Guillaume Nicolas, Dr. — Division of Nuclear Medicine, University Hospital Basel
- Study coordinator: Guillaume Nicolas, Dr.
- Email: guillaume.nicolas@usb.ch
- Phone: + 41 61 328 66 82
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuroendocrine Tumors, Radiolabeled somatostatin receptor ligands, SST PET/CT imaging, somatostatin receptor subtype 2, Tumor detection