TheranosticTrials.org

Clinical Trial · NCT06455358

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

Overview

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.

Sponsor

University Hospital, Basel, Switzerland

Phase

Phase 1/2

Contacts

Guillaume Nicolas, Dr. (CONTACT)

guillaume.nicolas@usb.ch

+ 41 61 328 66 82

Damian Wild, Prof. Dr. Dr. (CONTACT)

damian.wild@usb.ch

+41 61 32 86683

Guillaume Nicolas, Dr. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06455358

Drug / Compound

NODAGA-LM3

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: NODAGA

DOTATOC

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Estimated eGFR (CKD-EPI) ≥ 45 mL/min
  • 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
  • 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
  • Standard of care 68Ga-DOTATOC PET/CT performed or planned within max. 4 weeks prior or after IMP-administration, as clinically indicated
  • 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
  • Histologically proven well-differentiated bronchopulmonary (typical or atypical carcinoid) or gastroenteropancreatic neuroendocrine tumors (NET) of all grade (including NET G3 with Ki-67 \<30 %)

Exclusion

  • Presence of active infection at screening or history of serious infection within the previous 6 weeks
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the 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
  • 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
  • Pregnant or breast-feeding women