Neuroendocrine TumorsPhase 1/2NCT06455358
61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET)
A Phase 1/2 study testing 61Cu-NODAGA-LM3 and Comparator in people with Neuroendocrine Tumors, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- 61Cu-NODAGA-LM3 and Comparator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Feb 2025to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel, Department of Radiology and Nuclear Medicine
Basel, Canton of Basel-City, 4031
Guillaume Nicolas, Dr., + 41 61 328 66 82, guillaume.nicolas@usb.ch
Damian Wild, Prof. Dr. Dr., +41 61 32 86683, damian.wild@usb.ch
About this study
Official title: 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
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.
Read the detailed description
Neuroendocrine tumors (NET) originate from neuroendocrine cells and are most commonly found in the gastro-intestinal tract, pancreas and lung. Many NET grow slowly and are asymptomatic, leading to up to 50% being metastatic at diagnosis. Overexpression of somatostatin receptor subtype 2 (SST2) is a characteristic of NET and presents an important molecular target for the management of these tumors.
In Switzerland, two radiolabeled somatostatin analogues, gallium-68-labeled (68Ga)-DOTATOC and 68Ga-DOTATATE, are used for SST PET/CT imaging of well-differentiated neuroendocrine tumors. While these radiolabeled SST agonists provide high clinical performance and can be locally produced, they face limitations such as high costs, limited production capacity, short half-life hindering shipment to smaller centers, and high physiological uptake in organs like the liver, complicating tumor detection.
A novel copper-61 (61Cu) labeled somatostatin receptor antagonist, 61Cu-NODAGA-LM3, shows promise as an imaging agent for SST2 expressing tumors. It offers a longer half-life, enhanced tumor uptake and retention compared to established radiolabeled SST agonists, and improves image contrast.
This study aims to compare the safety and sensitivity of 61Cu-NODAGA-LM3 to the standard of care, 68Ga-DOTATOC, for SST PET/CT imaging in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors.
The results of the study potentially lead to enhanced diagnostic accuracy and patient care in the management of neuroendocrine tumors.
- Conditions
- Neuroendocrine Tumors
- Being tested
- 61Cu-NODAGA-LM3, Comparator
- Keywords
- Radiolabeled somatostatin receptor ligands, SST PET/CT imaging, somatostatin receptor subtype 2 (SST2), Tumor detection
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
61Cu-NODAGA-LM3Drug
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.
ComparatorOther
Also called 68Ga-DOTA-TOC
Single intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| 61Cu-NODAGA-LM3 PET/CT before 68Ga-DOTATOC PET/CT | Experimental | Participants randomized into this group undergo 61Cu-NODAGA-LM3 PET/CT between 24 hours to 4 weeks before routine 68Ga-DOTATOC PET/CT. Receives: Drug: 61Cu-NODAGA-LM3; Other: Comparator |
| 61Cu-NODAGA-LM3 PET/CT after 68Ga-DOTATOC PET/CT | Experimental | Participants randomized into this group undergo 61Cu-NODAGA-LM3 PET/CT between 24 hours to 4 weeks after routine 68Ga-DOTATOC PET/CT. Receives: Drug: 61Cu-NODAGA-LM3; Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 hour post injection
Secondary outcomes (13)
Positive predictive value of 61Cu-NODAGA-LM3 PET/CT
The sensitivity of 61Cu-NODAGA-LM3 PET/CT acquired ~ 1h and ~ 3h p.i. is compared with that of the standard of care 68Ga-DOTA-TOC PET/CT acquired ~1h p.i. in the same patients.
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.
Measured: 1 hour and 3 hours post injection
Dosimetry of 61Cu-NODAGA-LM3
Whole body and healthy organ absorbed dose (Gy) is determined in 6 patients by acquiring 3 time-point PET/CT imaging (~1h, ~3 and ~18h p.i.)
Measured: 1 hour, 3 and 18 hours post injection
Biodistribution of 61Cu-NODAGA-LM3
Tracer uptake distribution in organs is assessed in 6 patients visually and quantitatively (organ SUVmax, SUVpeak and SUVmean) on 61Cu-NODAGA-LM3 PET/CT scans acquired at ~1h and ~3h p.i.
Measured: 1 hour and 3 hours post injection
Peak plasma concentration (Cmax) of 61Cu-NODAGA-LM3
The peak plasma concentration (Cmax) of 61Cu-NODAGA-LM3 is determined in 6 patients by serial blood sampling up to max. ~18 h.
Measured: Baseline, 2, 5, 10, 20, and 30 min, 1 hour, 2, 4, and 18 hours post injection
Blood clearance of 61Cu-NODAGA-LM3
The blood clearance of 61Cu-NODAGA-LM3 is determined in 6 patients by serial blood sampling up to max. ~18 h.
Measured: Baseline, 2, 5, 10, 20, and 30 min, 1 hour, 2, 4, and 18 hours post injection
Area under the plasma concentration versus time curve (AUC) of 61Cu-NODAGA-LM3
The area under the plasma concentration versus time curve (AUC) of 61Cu-NODAGA-LM3 is determined in 6 patients by serial blood sampling up to max. ~18 h.
Measured: Baseline, 2, 5, 10, 20, and 30 min, 1 hour, 2, 4, and 18 hours post injection
Median of the median tumor uptake on 61Cu-NODAGA-LM3 PET/CT
The median of the mean tumor uptake (SUVmax) on 61Cu-NODAGA-LM3 PET/CT is determined at the best time-point for imaging and in comparison with 68Ga-DOTA-TOC PET/CT 1h p.i. for matched lesions only.
Measured: 1 hour and 3 hours post injection
Median of the mean tumor to background ratio at the best time-point for imaging
The median of the tumor to background ratio on 61Cu-NODAGA-LM3 PET/CT at the best time-point for imaging is compared with 68Ga-DOTA-TOC PET/CT 1h p.i. for matched lesions only.
Measured: 1 hour and 3 hours post injection
Differential Tumor detection rate
To determine the optimal imaging time-point, the difference between the tumor detection rate of 61Cu-NODAGA-LM3 PET/CT at ~1h and at ~3h p.i. is evaluated.
Measured: 1 hour and 3 hours post injection
Mean tumor to background ratio
To determine the optimal imaging time-point, the mean of the tumor to background ratio of 61Cu-NODAGA-LM3 PET/CT performed ~1h and ~3h p.i. is compared for matched lesions only.
Measured: 1 hour and 3 hours post injection
Mean signal to noise ratio
To determine the optimal imaging time-point, the mean signal to noise (SNR= SUVmax in Tumor VOI / Standard deviation in background VOI) of 61Cu-NODAGA-LM3 PET/CT is performed ~1h and ~3h post-injection for matched lesions only.
Measured: 1 hour and 3 hours post injection
Interreader variability is assessed in terms of sensitivity; number of TP/(TP + FN)
To determine the optimal imaging time-point, the interreader variability is assessed in terms of sensitivity (sensitivity = number of true positive (TP) divided by the number of true positive and number of false negative (FN)) of 61Cu-NODAGA-LM3 PET/CT (1 vs 3 h p.i) and 68Ga-DOTATOC PET/CT is evaluated.
Two independent blinded readers will assess the sensitivity of PET/CTs on a dedicated reading workstation using the software MIM Version 7.3.3.
Measured: 1 hour and 3 hours post injection
Patient's preference
To determine the optimal imaging time-point, the patient's preference is integrated by using a stress thermometer asking the patient to score their experience between the injection and scanning, and during scanning on a visual analogue scale, ranging from 0: not burdened at all to 10: extremely burdened.
Measured: Baseline, 1 hour and 3 hours post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start5 Feb 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Nicolas, Dr., Principal investigator, Division of Nuclear Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455358
- Sponsor's protocol ID
- 2023-01981; th22Nicolas
- Other IDs
- 2023
- Status last verified
- Feb 2025
- First submitted
- 30 May 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06455358
- Acronym / sponsor ID
- 2023-01981; th22Nicolas
- Conditions
- Neuroendocrine Tumors
- Keywords
- Radiolabeled somatostatin receptor ligands, SST PET/CT imaging, somatostatin receptor subtype 2 (SST2), Tumor detection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neuroendocrine tumors (NET) originate from neuroendocrine cells and are most commonly found in the gastro-intestinal tract, pancreas and lung. Many NET grow slowly and are asymptomatic, leading to up to 50% being metastatic at diagnosis. Overexpression of somatostatin receptor subtype 2 (SST2) is a characteristic of NET and presents an important molecular target for the management of these tumors.
In Switzerland, two radiolabeled somatostatin analogues, gallium-68-labeled (68Ga)-DOTATOC and 68Ga-DOTATATE, are used for SST PET/CT imaging of well-differentiated neuroendocrine tumors. While these radiolabeled SST agonists provide high clinical performance and can be locally produced, they face limitations such as high costs, limited production capacity, short half-life hindering shipment to smaller centers, and high physiological uptake in organs like the liver, complicating tumor detection.
A novel copper-61 (61Cu) labeled somatostatin receptor antagonist, 61Cu-NODAGA-LM3, shows promise as an imaging agent for SST2 expressing tumors. It offers a longer half-life, enhanced tumor uptake and retention compared to established radiolabeled SST agonists, and improves image contrast.
This study aims to compare the safety and sensitivity of 61Cu-NODAGA-LM3 to the standard of care, 68Ga-DOTATOC, for SST PET/CT imaging in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors.
The results of the study potentially lead to enhanced diagnostic accuracy and patient care in the management of neuroendocrine tumors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 61Cu-NODAGA-LM3 PET/CT before 68Ga-DOTATOC PET/CT | Experimental | Drug: 61Cu-NODAGA-LM3, Other: ComparatorParticipants 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 | Experimental | Drug: 61Cu-NODAGA-LM3, Other: ComparatorParticipants randomized into this group undergo 61Cu-NODAGA-LM3 PET/CT between 24 hours to 4 weeks after routine 68Ga-DOTATOC PET/CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 61Cu-NODAGA-LM3Single 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. | Drug | 61Cu-NODAGA-LM3 PET/CT after 68Ga-DOTATOC PET/CT, 61Cu-NODAGA-LM3 PET/CT before 68Ga-DOTATOC PET/CT |
| ComparatorAlso: 68Ga-DOTA-TOCSingle intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of standard clinical care. | Other | 61Cu-NODAGA-LM3 PET/CT after 68Ga-DOTATOC PET/CT, 61Cu-NODAGA-LM3 PET/CT before 68Ga-DOTATOC PET/CT |
Primary outcome
Frequency of adverse events (number)
Time frame: from Baseline up to 18 hours post injection
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.
Severity of adverse events assessed by CTCAE 5.0
Time frame: from Baseline up to 18 hours post injection
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.
Assessment of the sensitivity of 61Cu-NODAGA-LM3 PET/CT
Time frame: 1 hour post injection
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.
13 secondary outcomes
Positive predictive value of 61Cu-NODAGA-LM3 PET/CT
Time frame: 1 hour and 3 hours post injection
Dosimetry of 61Cu-NODAGA-LM3
Time frame: 1 hour, 3 and 18 hours post injection
Biodistribution of 61Cu-NODAGA-LM3
Time frame: 1 hour and 3 hours post injection
Peak plasma concentration (Cmax) of 61Cu-NODAGA-LM3
Time frame: Baseline, 2, 5, 10, 20, and 30 min, 1 hour, 2, 4, and 18 hours post injection
Blood clearance of 61Cu-NODAGA-LM3
Time frame: Baseline, 2, 5, 10, 20, and 30 min, 1 hour, 2, 4, and 18 hours post injection
Area under the plasma concentration versus time curve (AUC) of 61Cu-NODAGA-LM3
Time frame: Baseline, 2, 5, 10, 20, and 30 min, 1 hour, 2, 4, and 18 hours post injection
Median of the median tumor uptake on 61Cu-NODAGA-LM3 PET/CT
Time frame: 1 hour and 3 hours post injection
Median of the mean tumor to background ratio at the best time-point for imaging
Time frame: 1 hour and 3 hours post injection
Differential Tumor detection rate
Time frame: 1 hour and 3 hours post injection
Mean tumor to background ratio
Time frame: 1 hour and 3 hours post injection
Mean signal to noise ratio
Time frame: 1 hour and 3 hours post injection
Interreader variability is assessed in terms of sensitivity; number of TP/(TP + FN)
Time frame: 1 hour and 3 hours post injection
Patient's preference
Time frame: Baseline, 1 hour and 3 hours post injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume Nicolas, Dr. principal investigator
Division of Nuclear Medicine, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 61Cu-NODAGA-LM3 and Comparator in people with Neuroendocrine Tumors, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Nicolas, Dr. (+ 41 61 328 66 82, guillaume.nicolas@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (number) (time frame: from Baseline up to 18 hours post injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.