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

Last updated: February 17, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

1/2

Condition

Carcinoid Syndrome And Carcinoid Tumours

Digestive System Neoplasms

Abdominal Cancer

Treatment

61Cu-NODAGA-LM3

Comparator

Clinical Study ID

NCT06455358
2023-02982; th22Nicolas
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atypicalcarcinoid) 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 primarystaging, 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 prioror 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 beavailable in 5 additional patients

  • Estimated eGFR (CKD-EPI) ≥ 45 mL/min

  • If applicable, the last regular somatostatin analogue injection should beadministered 2 weeks +/- 1 week prior to SST PET scan for long acting release forms

Exclusion

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 theradionuclide used on such radiopharmaceutical including at any time during thecurrent study

  • Initiation or continuation of active anti-tumor treatment between 61Cu-NODAGA-LM3and 68Ga-DOTATOC PET/CT, except continuation of long acting somatostatin analogues

  • Presence of active infection at screening or history of serious infection within theprevious 6 weeks

  • Pregnant or breast-feeding women

  • History of somatic or psychiatric disease/condition that may interfere with theobjectives and assessments of the study

Study Design

Total Participants: 27
Treatment Group(s): 2
Primary Treatment: 61Cu-NODAGA-LM3
Phase: 1/2
Study Start date:
February 05, 2025
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • University Hospital Basel, Department of Radiology and Nuclear Medicine

    Basel, BS 4031
    Switzerland

    Active - Recruiting

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