61Cu-NODAGA-LM3 PET/CT for the Detection of Neuroendocrine Tumors (COPPER PET in NET)

NCT ID: NCT06455358

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-05
• Study Completion Date: 2028-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

61Cu-NODAGA-LM3 PET/CT before 68Ga-DOTATOC PET/CT

Participants randomized into this group undergo 61Cu-NODAGA-LM3 PET/CT between 24 hours to 4 weeks before routine 68Ga-DOTATOC PET/CT.

Group Type: EXPERIMENTAL

61Cu-NODAGA-LM3

Intervention Type: DRUG

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.

Comparator

Intervention Type: OTHER

Single intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of standard clinical care.

61Cu-NODAGA-LM3 PET/CT after 68Ga-DOTATOC PET/CT

Participants randomized into this group undergo 61Cu-NODAGA-LM3 PET/CT between 24 hours to 4 weeks after routine 68Ga-DOTATOC PET/CT.

Group Type: EXPERIMENTAL

61Cu-NODAGA-LM3

Intervention Type: DRUG

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.

Comparator

Intervention Type: OTHER

Single intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of standard clinical care.

Interventions

61Cu-NODAGA-LM3

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.

Intervention Type: DRUG

Comparator

Single intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of standard clinical care.

Intervention Type: OTHER

Other Intervention Names

68Ga-DOTA-TOC

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Nicolas, Dr.

Role: PRINCIPAL_INVESTIGATOR

Division of Nuclear Medicine, University Hospital Basel

Locations

University Hospital Basel, Department of Radiology and Nuclear Medicine

Basel, Canton of Basel-City, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Guillaume Nicolas, Dr.

Role: CONTACT

guillaume.nicolas@usb.ch

+ 41 61 328 66 82

Damian Wild, Prof. Dr. Dr.

Role: CONTACT

damian.wild@usb.ch

+41 61 32 86683

Facility Contacts

Guillaume Nicolas, Dr.

Role: primary

guillaume.nicolas@usb.ch

+ 41 61 328 66 82

Damian Wild, Prof. Dr. Dr.

Role: backup

damian.wild@usb.ch

+41 61 32 86683

Other Identifiers

2023-01981; th22Nicolas

Identifier Type: -

Identifier Source: org_study_id