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NCT04318561: PET
Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors
Phase 1, PHASE2 trial testing Gallium-68 NODAGA-LM3 PET/CT in Neuroendocrine Tumors in 40 participants. Completed in 1 December 2021.
1 December 2021
Quick facts
| Lead sponsor | Peking Union Medical College Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 40 |
| Start date | 1 December 2019 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Gallium-68 NODAGA-LM3 PET/CT
- Gallium-68 DOTA-LM3 PET/CT
- Gallium-68 DOTATATE PET/CT
Conditions studied
- Neuroendocrine Tumors — all drugs for Neuroendocrine Tumors →
Sponsor
Peking Union Medical College Hospital
Who can join
Adults 18 to 70, any sex, with Neuroendocrine Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
LM3 is a novel somatostatin receptor antagonist, while Gallium-68 DOTATATE is a typical somatostatin receptor agonist, This study is to evaluate the safety, biodistribution, dosimetry, and lesion detection ability of Gallium-68 labeled somatostatin receptor antagonist LM3 for the diagnostic imaging of metastatic, well-differentiated neuroendocrine tumors using positron emission tomography / computed tomography (PET/CT). The results will be compared between antagonist Gallium-68 labeled LM3 and agonist Gallium-labeled DOTATATE in the same group of patients. It will also be compared between the two different antagonists, Gallium-68 DOTA-LM3 and Gallium-68 NODAGA-LM3, in two parallel-designed arms.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
A prospective randomized, double-blind study to evaluate the diagnostic efficacy of <sup>68</sup>Ga-NODAGA-LM3 and <sup>68</sup>Ga-DOTA-LM3 in patients with well-differentiated neuroendocrine tumors: compared with <sup>68</sup>Ga-DOTATATE.
Zhu W, Jia R, Yang Q, Cheng Y, et al · · 2022 · cited 29× · PMID 34874478 · DOI 10.1007/s00259-021-05512-y -
A Prospective, Randomized, Double-Blind Study to Evaluate the Safety, Biodistribution, and Dosimetry of <sup>68</sup>Ga-NODAGA-LM3 and <sup>68</sup>Ga-DOTA-LM3 in Patients with Well-Differentiated Neuroendocrine Tumors.
Zhu W, Cheng Y, Jia R, Zhao H, et al · · 2021 · cited 24× · PMID 33579804 · DOI 10.2967/jnumed.120.253096 -
Peptide Radioligands in Cancer Theranostics: Agonists and Antagonists.
Nock BA, Kanellopoulos P, Joosten L, Mansi R, et al · · 2023 · cited 23× · PMID 37242457 · DOI 10.3390/ph16050674 -
The neuroscience of cancer: Focus on neuropeptidergic systems.
Dong Z, Wang Y, Jin W. · · 2025 · cited 3× · PMID 40487638 · DOI 10.1016/j.apsb.2025.03.025
Verify or expand the search:
- PubMed search for NCT04318561
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Peking Union Medical College Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04318561 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking Union Medical College Hospital
- Last refreshed: 21 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04318561.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing