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

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT06455358
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 61Cu-NODAGA-LM3 — 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 — OTHER
    Single intravenous administration of 68Ga-DOTA-TOC and PET/CT acquisitions as part of standard clinical care.

Study Details

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.

Key Dates

First listed
Jun 12, 2024
Start date
Feb 5, 2025
Status verified
Feb 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Frequency of adverse events (number) [ Time Frame: from Baseline up to 18 hours post injection ]

Central Contacts

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