61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET)
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 12, 2024
CompletedStudy Start
First participant enrolled
February 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
May 30, 2025
February 1, 2025
3.3 years
May 30, 2024
May 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Frequency of adverse events (number)
The safety of 61Cu-NODAGA-LM3 is assessed in a primary safety analysis that is descriptive in nature and is performed in the safety analysis set, including information about the frequency (number) of adverse events.
from Baseline up to 18 hours post injection
Severity of adverse events assessed by CTCAE 5.0
The safety of 61Cu-NODAGA-LM3 is assessed in a primary safety analysis that is descriptive in nature and is performed in the safety analysis set, including information about the severity of adverse events. Severity will be graded as per CTCAE (Common Terminology Criteria for Adverse Events) Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting ageappropriate instrumental ADL (Activities of Daily Living). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
from Baseline up to 18 hours post injection
Assessment of the sensitivity of 61Cu-NODAGA-LM3 PET/CT
The sensitivity of 61Cu-NODAGA-LM3 PET/CT acquired \~ 1h p.i. is compared with that of the standard of care 68Ga-DOTA-TOC PET/CT acquired \~1h p.i.. Sensitivity is determined based on the adjudication of all suspected lesions (union of the sets of lesions detected by two blinded independent readers) against a gold standard. The gold standard is defined either as a biopsy whenever possible and if clinically indicated or a comparison to the best imaging modality for the patient given case 2 - 7 months during follow up. After all "true" lesions are identified on all images, it is determined whether or not a given lesion has been identified on the 61Cu-NODAGA-LM3 PET/CT and on the 68Ga-DOTA-TOC PET/CT scans.
1 hour post injection
Secondary Outcomes (13)
Positive predictive value of 61Cu-NODAGA-LM3 PET/CT
1 hour and 3 hours post injection
Dosimetry of 61Cu-NODAGA-LM3
1 hour, 3 and 18 hours post injection
Biodistribution of 61Cu-NODAGA-LM3
1 hour and 3 hours post injection
Peak plasma concentration (Cmax) of 61Cu-NODAGA-LM3
Baseline, 2, 5, 10, 20, and 30 min, 1 hour, 2, 4, and 18 hours post injection
Blood clearance of 61Cu-NODAGA-LM3
Baseline, 2, 5, 10, 20, and 30 min, 1 hour, 2, 4, and 18 hours post injection
- +8 more secondary outcomes
Other Outcomes (4)
Optimal injected activity of 61Cu-NODAGA-LM3
1 hour and 3 hours post injection
Tumor detection rate of 61Cu-NODAGA-LM3 PET/CT
1 hour and 3 hours post injection
Correlation of tumor and organ uptake on 61Cu-NODAGA-LM3 PET/CT and quantitated post-treatment SPECT/CT
1 hour and 3 hours post injection
- +1 more other outcomes
Study Arms (2)
61Cu-NODAGA-LM3 PET/CT before 68Ga-DOTATOC PET/CT
EXPERIMENTALParticipants randomized into this group undergo 61Cu-NODAGA-LM3 PET/CT between 24 hours to 4 weeks before routine 68Ga-DOTATOC PET/CT.
61Cu-NODAGA-LM3 PET/CT after 68Ga-DOTATOC PET/CT
EXPERIMENTALParticipants randomized into this group undergo 61Cu-NODAGA-LM3 PET/CT between 24 hours to 4 weeks after routine 68Ga-DOTATOC PET/CT.
Interventions
Single intravenous administration of 61Cu-NODAGA-LM3 at an amount of 20 -40 μg (or 13 - 26 nmol) and an activity range of 150 MBq (±25%) followed by up to three PET/CT acquisitions.
Single intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of standard clinical care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel, Department of Radiology and Nuclear Medicine
Basel, Canton of Basel-City, 4031, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillaume Nicolas, Dr.
Division of Nuclear Medicine, University Hospital Basel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 12, 2024
Study Start
February 5, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
May 30, 2025
Record last verified: 2025-02