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Trial Title:
61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET)
NCT ID:
NCT06455358
Condition:
Neuroendocrine Tumors
Conditions: Official terms:
Neuroendocrine Tumors
Edotreotide
Conditions: Keywords:
Radiolabeled somatostatin receptor ligands
SST PET/CT imaging
somatostatin receptor subtype 2 (SST2)
Tumor detection
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
61Cu-NODAGA-LM3
Description:
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.
Arm group label:
61Cu-NODAGA-LM3 PET/CT after 68Ga-DOTATOC PET/CT
Arm group label:
61Cu-NODAGA-LM3 PET/CT before 68Ga-DOTATOC PET/CT
Intervention type:
Other
Intervention name:
Comparator
Description:
Single intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of
standard clinical care.
Arm group label:
61Cu-NODAGA-LM3 PET/CT after 68Ga-DOTATOC PET/CT
Arm group label:
61Cu-NODAGA-LM3 PET/CT before 68Ga-DOTATOC PET/CT
Other name:
68Ga-DOTA-TOC
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Basel, Department of Radiology and Nuclear Medicine
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Contact:
Last name:
Guillaume Nicolas, Dr.
Phone:
+ 41 61 328 66 82
Email:
guillaume.nicolas@usb.ch
Contact backup:
Last name:
Damian Wild, Prof. Dr. Dr.
Phone:
+41 61 32 86683
Email:
damian.wild@usb.ch
Investigator:
Last name:
Guillaume Nicolas, Dr.
Email:
Principal Investigator
Start date:
June 2024
Completion date:
June 2028
Lead sponsor:
Agency:
University Hospital, Basel, Switzerland
Agency class:
Other
Source:
University Hospital, Basel, Switzerland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06455358
