NANETS2025 18th Annual Multidisciplinary NET Medical Symposium NANETS 2025 Clinical – Nuclear Medicine/Interventional Radiology/Imaging (22 abstracts)
61Cu-NODAGA-LM3 versus 68Ga-DOTATOC in the same patients with neuroendocrine tumors: Preliminary results of the Phase I/II COPPER-PET-in-NET Trial
Guillaume Pierre Nicolas 1 , Alin Chirindel 1 , Felix Kaul 1 , Lisa McDougall 1 , Anass Johayem 3 , Angela Llamazares 3 , Markus Baier 4 , Nicole Schubert 4 , Francesco De Rose 4 , Ben Pais 4 , Leila Jaafar 4 , Manuel Alejandre Lafont 1 , Andreas Bauman 1 , Melpomeni Fani 1 & Damian Wild 1
1Department Theragnostics, University Hospital Basel, Switzerland; 2Department of Clinical Research, University Hospital Basel, Switzerland; 3Department of Nuclear Medicine, University Hospital Zurich, University of Zurich, Switzerland; 4Nuclidium AG, Basel, Switzerland
Background: (Pre)clinical data suggest that somatostatin receptor (sstr) antagonists, when radiolabeled with gallium-68, offer superior imaging performance over agonists in patients with neuroendocrine tumors (NETs). 61Cu-NODAGA-LM3 is a novel PET tracer targeting sstr2 that may overcome key limitations of [68Ga]-based tracers, including production capacity, image resolution, and logistics. Cyclotron-produced 6¹Cu and has a longer half-life compared to 68Ga or 18F, supporting delayed imaging and easier logistics. Additionally, 61Cu has a higher positron fraction than 64Cu , enhancing image quality per administered activity. We report first-in-human data on 6¹Cu-NODAGA-LM3 covering safety, biodistribution, dosimetry, pharmacokinetics, image quality, and lesion detection.
Methods: In this ongoing, randomized, crossover, controlled, reader-blind, phase I/II PET/CT trial (NCT06455358), 23 patients with sstr2-positive, well-differentiated gastroenteropancreatic or bronchopulmonary NETs receive both 6¹Cu-NODAGA-LM3 (1h and 3h post-injection) and 68Ga-DOTA-TOC PET/CT (1h post-injection) on the same scanner. Imaging is conducted within 28 days and, if applicable, 14±2 days post last somatostatin analogue injection. Co-primary endpoints are safety and sensitivity of 6¹Cu-NODAGA-LM3 with noninferiority of sensitivity against 68Ga-DOTA-TOC using mixed-effects logistic regression. Biopsy and/or composite imaging during 2–7 months of follow-up serve as gold standard. Adverse events are monitored up to one day post-injection (p.i) (CTCAE v5.0). Secondary endpoints include biodistribution, pharmacokinetics, dosimetry, and lesion detection. Six patients undergo additional imaging at 18h p.i. for dosimetry, and 1h vs. 3h p.i. images are compared to define optimal imaging time.
Results: To date, 20 patients completed imaging; 6 had full dosimetry. No clinically significant adverse events occurred. 6¹Cu-NODAGA-LM3 showed rapid biexponential blood clearance (median 234 mL/min [IQR: 139–365]; R²>0.99) and a short distribution phase (median α half-life: 34 min [IQR: 25–37]). Biodistribution was favorable, with similar bone marrow uptake at 1h p.i. (SUVmax Th6: 1.0 [IQR: 0.9–1.3] vs. 1.1 [IQR: 1.0–1.4] for 6¹Cu-NODAGA-LM3 vs. 68Ga-DOTA-TOC), but significantly lower liver (3.1 vs. 6.4) and spleen (9.0 vs. 24.0) uptake (P < 0.001 and 0.002). Median tumor SUVmax at 1h p.i. for the three hottest matched lesions was 12% higher with 6¹Cu-NODAGA-LM3 (19.6 vs. 16.9), enhancing lesion detection and tumor-to-background contrast. Median effective dose was 5.0 mSv [4.2–5.7]. In blinded review, image quality was rated superior with 6¹Cu-NODAGA-LM3 in 16 of 20 cases and equivalent in the remaining 4.
Conclusions: These preliminary data support 6¹Cu-NODAGA-LM3 as a safe, effective sstr2-targeting tracer with favorable pharmacokinetics, biodistribution, dosimetry, with logistical and diagnostic advantages over 68Ga-labeled somatostatin receptor agonist-based imaging in patients with NETs.
Abstract ID #33431
Article tools
My recent searches
My recently viewed abstracts
Authors
Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
© Bioscientifica 2026 |
Privacy policy |
Cookie settings
BiosciAbstracts
Bioscientifica Abstracts is the gateway to a series of products that provide a permanent, citable record of abstracts for biomedical and life science conferences.
Find out more